Apparatus and method for developing an anatomic space for laparoscopic procedures with laparoscopic visualization

ABSTRACT

A laparoscopic apparatus for tunneling dissection including a hollow tunneling member and an inflatable balloon disposed at the distal end of the tunneling member to form together a blunt tipped obturator. The tunneling member has a bore sized allow the insertion of a conventional laparoscope therein to provide observation during surgical procedures. The laparoscope provides direct observation of dissection through the open distal end of the tunneling member. Observation is provided both when the device is used to tunnel between tissue layers to a region of interest within the body of a patient, and during subsequent balloon inflation when the tissue layers are dissected to cause separation of the tissue layers and the creation of an anatomical working space. After the anatomic space has been created, the device and laparoscope are withdraw through the incision. If needed, a trocar can be inserted into the incision to provide access back to the previously created space where the surgical procedure is to be performed. The anatomic working space may be insufflated with an insufflation gas if required for the particular procedure. The apparatus is prepared for use by inserting the tunneling member into the interior of the balloon, forming the balloon into a generally cylindrical roll about the tunneling member, and preferably, through the use of an integral balloon cover, securing the balloon roll to the tunneling member to form a semi-rigid blunt tipped obturator.

[0001] This is a continuation of U.S. application Ser. No. 08/484,208,filed on Jun. 7, 1995, which is a continuation of U.S. application Ser.No. 08/403,012, filed on Mar. 10, 1995, now U.S. Pat. No. 5,540,711,which is a continuation-in-part of U.S. application Ser. No. 08/388,233filed on Feb. 13, 1995, now U.S. Pat. No. 5,730,756, which is acontinuation-in-part of U.S. application Ser. No. 08/267,488, filed onJun. 29, 1994, now U.S. Pat. No. 5,607,443, which is acontinuation-in-part of U.S. application Ser. No. 08/124,283, filed onSep. 20, 1993, which is a continuation-in-part of U.S. application Ser.No. 07/893,988 filed on Jun. 2, 1992. The disclosure of each of theseprior applications is hereby incorporated by reference in theirentirety.

[0002] This invention relates generally to an apparatus and method fordeveloping an anatomic space for laparoscopic procedures, and morespecifically, to an apparatus and method that provides for laproscopicvisualization both during tunneling dissection to the desired anatomicspace as well as during subsequent tissue dissection during ballooninflation once the desired potential space has been identified.

[0003] In the past, in developing spaces and potential spaces within abody, blunt dissectors or soft-tipped dissectors have been utilized tocreate a dissected space which is parallel to the plane in which thedissectors are introduced into the body tissue. This often may be in anundesired plane, which can lead to bleeding which may obscure the fieldand make it difficult to identify the body structures. In utilizing suchapparatus and methods, attempts have been made to develop anatomicspaces in the anterior, posterior or lateral to the peritoneum. The sameis true for pleural spaces and other anatomic spaces. Procedures thathave been performed in such spaces include varicocele dissection, lymphnode dissection, sympathectomy and hernia repair. In the past, theinguinal hernia repair has principally been accomplished by the use ofan open procedure which involves an incision in the groin to expose thedefect in the inguinal floor, remove the hernial sac and subsequentlysuture the ligaments and fascias together to reinforce the weakness inthe abdominal wall. Recently, laparoscopic hernia repairs have beenattempted by inserting laparoscopic instruments into the abdominalcavity through the peritoneum and then placing a mesh patch over thehernia defect. Hernia repair using this procedure has a number ofdisadvantages, principally because the mesh used for hernia repair is indirect contact with the structures in the abdominal cavity, as forexample the intestines, so that there is a tendency for adhesions toform in between these structures. Such adhesions are known to beresponsible for certain occasionally serious complications. Such aprocedure is also undesirable because typically the patch is stapledinto the peritoneum, which is a very thin unstable layer covering theinner abdomen. Thus, the stapled patch can tear away from the peritoneumor shift its position. Other laparoscopic approaches involve cuttingaway the peritoneum and stapling it closed. This is time consuming andinvolves the risk of inadvertent cutting of important anatomicstructures. In addition, such a procedure is undesirable because itrequires the use of a general anesthesia. There is therefore a need fora new and improved apparatus and method for developing an anatomic spaceand particularly for accomplishing hernia repair by laparoscopy.

[0004] In general, it is an object of the present invention to providean apparatus and method for developing an anatomic space.

[0005] Another object of the invention is to provide an apparatus andmethod in which such an anatomic space is developed by applyingperpendicular forces to create the anatomic space at the weakest planeto create a more natural, less traumatic and bloodless region in whichto work.

[0006] Another object of the invention is to provide an apparatus andmethod to obtain surgical exposure in the preperitoneal space.

[0007] Another object of the invention is to provide an apparatus andmethod to create an extraperitoneal working space utilizing a balloondissector.

[0008] Another object of the present invention is to provide anapparatus and method of the above character for developing an anatomicspace for laparoscopic hernia repair through the anatomic space.

[0009] Another object of the invention is to provide an apparatus andmethod for decreasing the time and risk associated with creating apreperitoneal working space.

[0010] Another object of the present invention is to provide anapparatus and method of the above character for developing an anatomicspace for laparoscopic hernia repair through the anatomic space.

[0011] Another object of the invention is to provide an apparatus andmethod of the above character which requires a minimally invasiveprocedure.

[0012] Another object of the invention is to provide an apparatus andmethod of the above character which can be accomplished without the useof a general anesthesia.

[0013] Another object of the invention is to provide an apparatus andmethod of the above character which can be accomplished with a spinal orepidural anesthesia.

[0014] Another object of the invention is to provide an apparatus andmethod of the above character which provides substantially reducedmedical costs and a greatly reduced patient recovery time.

[0015] Another object of the invention is to provide an apparatus of theabove character which is relatively simple and compact.

[0016] Another object of the invention is to provide an apparatus andmethod of the above character which can be readily utilized by surgeons.

[0017] Another object of the invention is to provide a patch for use inthe apparatus which is firmly secured during the hernia repair.

[0018] Another object of the invention is to provide a balloon which hasa modified asymmetric manta ray configuration to aid in providing thedesired configuration for the extraperitoneal working space for herniarepair.

[0019] Another object of the invention is to provide a balloondissection apparatus in which the balloon cover is detachably secured tothe obturator so that the balloon dissection device is relatively rigidto permit the balloon dissection apparatus to be grasped by the handleto operate the same during dissection.

[0020] Another object of the invention is to provide a balloondissection apparatus of the above character in which a precise releasemechanism is provided for releasing the balloon cover from the obturatorso that the surgeon can be assured that the balloon cover has beenreleased before it is removed to release the balloon.

[0021] Another object of the invention is to provide a balloondissection apparatus of the above character in which the guide rod orobturator remain in place to maintain ready access to theextraperitoneal working space.

[0022] Another object of the invention is to provide a balloondissection apparatus of the above character in which certain of theparts which are to be moved relative to other parts are color coded toaid the surgeon in use of the apparatus.

[0023] Another object of the apparatus is to provide an introducermember which is provided with a tip having an inclined surface.

[0024] Another object of the invention is to provide a balloondissection apparatus which is provided with a blunt tip which has adiameter which is less than the diameter of the cannula tube.

[0025] Another object of the invention is to provide a balloondissection apparatus of the above character in which at least a part ofthe same can be sterilized and reused.

[0026] Another object of the invention is to provide an apparatus andmethod of the above character which has been simplified.

[0027] Another object of the invention is to provide an apparatus andmethod of the above character which decreases the number of stepsrequired to complete a dissection process.

[0028] Another object of the invention is to provide an apparatus andmethod which permits a visualization of the insertion of the ballooninto the posterior rectus space at the time of insertion.

[0029] Another object of the invention is to provide an apparatus of theabove character which makes it possible to utilize conventionalcannulae.

[0030] Another object of the invention is to provide an apparatus of theabove character which makes it possible to utilize a laparoscope duringthe surgical procedure to permit viewing of the dissection as it isoccurring.

[0031] Another object of the invention is to provide an apparatus of theabove character in which laparoscopic observation can be accomplishedthrough the balloon if desired as dissection is taking place.

[0032] Another object of the invention is to provide an apparatus of theabove character in which a separate removable sheath is not required forencasing the balloon prior to inflation.

[0033] Another object of the invention is to provide an inflatableballoon which can be utilized to dissect around obstructions.

[0034] Another object of the invention is to provide a balloon utilizedfor dissection which is provided in laterally inwardly extending foldsto aid in dissecting as the balloon is inflated.

[0035] Another object of the invention is to provide a laparoscopicapparatus including a tunneling member, channel guide and balloonassembly into which a conventional laparoscope may be inserted forvisualization of anatomic structures as the tunneling member andlaparoscope are advanced through an incision to the desired locationwithin the body where dissection of tissue layers is desired.

[0036] Another object of the invention is to provide a tunneling memberand balloon assembly of the above character wherein the tunneling memberhas an open distal end that permits a laparoscope to be advanced outsidethe tunneling member into the interior of the balloon during ballooninflation to permit observation of tissue dissection through a singleballoon layer.

[0037] Another object of the invention is to provide a tunneling memberand balloon assembly of the above character which includes a U shapedchannel guide that remains within the incision site after the tunnelingmember and laparoscope are withdrawn to provide reliable access back tothe previously created space.

[0038] Another object of the invention is to provide an apparatus of theabove character in which a separate removable sheath is not required tocover the balloon prior to inflation.

[0039] Another object of the invention is to provide an apparatus of theabove character which includes an optional endoscope guide which may beinserted into the incision during tunneling dissection to preserveaccess to the created space for subsequent laparoscopic procedures.

[0040] Additional objects and features of the invention will appear fromthe following description in which the preferred embodiments are setforth in detail in conjunction with the accompanying drawings.

[0041]FIG. 1 is a side elevational view partially in cross-section of alaparoscopic apparatus incorporating the present invention.

[0042]FIG. 2 is a cross-sectional view taken along the 2-2 of FIG. 1.

[0043]FIG. 3 is a side elevational view partially in cross-section ofthe tunneling shaft forming a part of the apparatus shown in FIG. 1after it has been removed from the apparatus shown in FIG. 1.

[0044]FIG. 4 is a cross-sectional view taken along the line 4-4 of FIG.3.

[0045]FIG. 5 is an isometric view of the inflatable balloon utilized inthe apparatus in FIG. 1 secured to the tunneling rod.

[0046]FIG. 6 is a cross-sectional view taken along the line 6-6 of FIG.5, and showing by dotted lines the manner in which the balloon as itunfolds develops the anatomic space.

[0047]FIG. 7 is a partial plan view of a prone human body, showing thelower abdomen showing the manner in which the laparoscopic apparatus ofthe present invention is utilized for performing a hernia repair throughthe preperitoneal space.

[0048]FIG. 8 is a sagittal view of the lower abdominal cavity of thehuman being shown in FIG. 7 showing the apparatus of the presentinvention introduced into the preperitoneal space.

[0049]FIG. 9 is a view similar to FIG. 8 but showing the sleeve removedfrom the apparatus and with the balloon inflated.

[0050]FIG. 10 is a sagittal view similar to FIG. 8 showing the balloondeflated and being removed.

[0051]FIG. 11 is a sagittal view similar to FIG. 8 showing removal ofthe tunnelling shaft.

[0052]FIG. 12 is an isometric view of a patch incorporating the presentinvention.

[0053]FIG. 13 is a side elevational view of the patch shown in FIG. 12.

[0054]FIG. 14 is an isometric view showing the patch in FIGS. 12 and 13in a rolled-up, generally cylindrical configuration.

[0055]FIG. 15 is a sagittal view showing the hernia sac of hernia thatis to be repaired.

[0056]FIG. 16 is a sagittal view showing the introducer through whichthe rolled-up patch in FIG. 17 has been introduced into thepreperitoneal space by an introducer rod.

[0057]FIG. 17 is a sagittal view similar to FIG. 16 showing theattachment of the patch to the hernia sac.

[0058]FIG. 18 is a sagittal view similar to FIG. 17 showing thedissection of the hernia sac and the unrolling of the patch.

[0059]FIG. 19 is a sagittal view showing the patch in place to providethe hernia repair.

[0060]FIG. 20 is an isometric view of another embodiment of a balloonwith a patch disposed thereon for use with the apparatus of the presentinvention.

[0061]FIG. 21 is a cross-sectional view taken along the line 21-21 ofFIG. 20.

[0062]FIG. 22 is an enlarged cross-sectional view taken along the line22-22 of FIG. 23.

[0063]FIG. 23 is a sagittal view showing the manner in which the balloonand patch shown in FIG. 20 are disposed in the preperitoneal space.

[0064]FIG. 24 is a sagittal view showing the placement of the balloonand the patch of FIG. 20, and the inflation of the balloon in thepreperitoneal space.

[0065]FIG. 25 is an isometric view of another embodiment of a balloonand patch for use with the apparatus of the present invention.

[0066]FIG. 26 is a rolled-up cross-sectional view of the balloon andpatch shown in FIG. 25.

[0067]FIG. 27 is an isometric view of another embodiment of a patch foruse with the apparatus of the present invention.

[0068]FIG. 28 is an isometric view of the patch shown in FIG. 27 wrappedin an introducer assembly.

[0069]FIG. 29 is a top plan view of another embodiment of a laparoscopicapparatus incorporating the present invention.

[0070]FIG. 30 is a side elevational view taken along the line 30-30 ofFIG. 29.

[0071]FIG. 31 is a cross-sectional view taken along the line 31-31 ofFIG. 30.

[0072]FIG. 32 is a cross-sectional view taken along the line 32-32 ofFIG. 30.

[0073]FIG. 33 is an enlarged cross-sectional view of the distalextremity of the laparoscopic apparatus shown in FIG. 29.

[0074]FIG. 34 is a partial plan view showing the balloon after it hasbeen removed from the laparoscopic apparatus with the obturator tipshifting its position.

[0075]FIG. 35 is a plan view of the balloon shown in FIG. 34 as it isbeing removed from the body of the patient and bringing along with itthe obturator tip.

[0076]FIG. 36 is a side elevational view of another embodiment of alaparoscopic apparatus incorporating the present invention.

[0077]FIG. 37 is a plan view showing the balloon from the apparatusshown in FIG. 36 in an inflated condition and showing the tunneling rodmounted therein being prevented from being advanced beyond the distalextremity of the balloon.

[0078]FIG. 38 is a plan view showing the manner in which the balloon isseparated from the tunneling rod as it is retracted.

[0079]FIG. 39 is an isometric view of a surgical dissector with acannula incorporating the present invention in an assembled condition.

[0080]FIG. 40 is an isometric exploded view of the components of thesurgical dissector with cannula shown in FIG. 39.

[0081]FIG. 41 is a side elevational view of the assembly shown in FIG.39.

[0082]FIG. 42 is a top plan view looking along the line 42-42 of FIG.41.

[0083]FIG. 43 is a view partly in cross section taken along the line43-43 of FIG. 42.

[0084]FIG. 44 is a view looking along the line 44-44 of FIG. 41.

[0085]FIG. 45 is a partial side elevational view of the assembly shownin FIG. 1 with the clamping mechanism moved to a release position.

[0086]FIG. 46 is a view taken along the line 46-46 of FIG. 45.

[0087]FIG. 47 is a partial side elevational view of an assembly shown inFIG. 41 with the retaining ring moved to a locked position.

[0088]FIG. 48 is a cross-sectional view taken along the line 48-48 ofFIG. 47.

[0089] FIGS. 49A-49G are cartoons showing use of the surgical dissectorshown in FIG. 1 in a laparoscopic hernia procedure.

[0090]FIG. 50 is a cross-sectional view taken along the line 50-50 ofFIG. 49C.

[0091]FIG. 51 is a cross-sectional view taken along the line 51-51 ofFIG. 52 showing another embodiment of a balloon dissection apparatusincorporating the present invention.

[0092]FIG. 52 is an end elevational view taken along the line 52-52 ofFIG. 51.

[0093]FIG. 53 is an enlarged cross-sectional view taken along the line53-53 of FIG. 51.

[0094]FIG. 54 is an enlarged cross-sectional view taken along the line54-54 of FIG. 53.

[0095]FIG. 55 is an enlarged cross-sectional view of a portion of theview shown in FIG. 51 showing the latch members moved to permit removalof the guide rod.

[0096]FIG. 56 is a side elevational view of another embodiment of alaparoscopic apparatus incorporating the present invention showing theballoon in a collapsed condition and packaged in a roll.

[0097]FIG. 57 is a side elevational view of the obturator shaft utilizedas a part of the laparoscopic apparatus shown in FIG. 56.

[0098]FIG. 57A is an enlarged partial cross-sectional view of the distalextremity of the obturator shaft shown in FIG. 57.

[0099]FIG. 57B is a view similar to FIG. 57A for use with a laparoscopehaving a centrally disposed lens for viewing.

[0100]FIG. 58 is an isometric view of the apparatus shown in FIG. 56with the balloon inflated but in a rolled out condition.

[0101]FIG. 59 is a cross-sectional view taken along the line 59-59 ofFIG. 58.

[0102]FIG. 60 is an isometric view showing the manner in which a sheetof non-elastomeric material is utilized to form the balloon of thepresent invention shown in the embodiments in FIGS. 58 and 59.

[0103]FIG. 61 is an isometric view similar to that shown in FIG. 60 butshowing another subsequent step for making the balloon of the presentinvention.

[0104]FIG. 62 is another isometric view similar to FIGS. 60 and 61showing still another step in making the balloon of the presentinvention.

[0105]FIG. 63 is a cross-sectional view taken along the line 63-63 ofFIG. 56.

[0106]FIG. 64 is a cross-sectional view of a balloon incorporating theinvention showing the balloon provided with laterally and inwardlyextending folds.

[0107]FIG. 65 is a schematic illustration of a balloon dissectionapparatus incorporating the present invention which can be utilized inconnection with dissecting around an obstruction.

[0108]FIG. 66 is a plan view showing the bifurcated balloon in FIG. 65partially unrolled.

[0109]FIG. 67 is a plan view illustrating the balloon in FIG. 66 havingone of its legs everting around an obstruction.

[0110]FIG. 68 is a plan view illustrating the balloon in FIG. 66 havingboth legs of the bifurcated balloon everted to create dissection aroundthe obstruction.

[0111]FIG. 69 is a plan view of another embodiment of a laparoscopicapparatus incorporating the present invention.

[0112]FIG. 70 is another plan view showing another embodiment of alaparoscopic apparatus incorporating the present invention.

[0113]FIG. 71 is a plan view showing another embodiment of alaparoscopic apparatus incorporating the present invention.

[0114]FIG. 72 is a side elevational view taken along the lines 72-72 ofFIG. 71.

[0115]FIG. 73 is an enlarged partial cross-sectional view of a portionof the apparatus shown in FIG. 71.

[0116]FIG. 74 is a plan view partially in cross-section showing anotherembodiment of the laparoscopic apparatus incorporating the presentinvention.

[0117]FIG. 75 is an isometric view illustrating another embodiment of alaparoscopic apparatus incorporating the present invention.

[0118]FIG. 76 is an isometric view of the laparoscopic apparatus of FIG.75 with the laparoscope and tunneling member removed and the balloonopened up to assume a manta ray shape in accordance with one aspect ofthe present invention.

[0119]FIG. 77 is a cross-sectional view taken along line 77-77 in FIG.76 illustrating the cross section of a balloon with an integral ballooncover according to aspects of the invention.

[0120] FIGS. 78A-C are plan, side elevational and end views,respectively, of a channel guide according to the invention.

[0121]FIG. 79 is an isometric view of the tunneling member removed fromthe FIG. 75 laparoscopic apparatus illustrating the open distal end inaccordance with the invention.

[0122]FIG. 80 is a side elevational view partially in cross-section thatillustrates the distal end of a conventional laparoscope extendingoutside the distal end of the tunneling member according to one aspectof the invention.

[0123]FIG. 81 is a cross-sectional view taken along line 81-81 in FIG.75 that illustrates a rolled up balloon with integral balloon coveraccording to the invention.

[0124]FIG. 82 is a cross-sectional view of the proximal end of the FIG.75 laparoscopic apparatus.

[0125]FIG. 83 is a cartoon showing the use of the laparoscopic apparatusshown in FIG. 75 in a laparoscopic hernia repair.

[0126]FIG. 84 is an isometric view of another embodiment of alaparoscopic apparatus incorporating the present invention.

[0127]FIG. 85 is an isometric view of still another embodiment of alaparoscopic apparatus incorporating the present invention.

[0128]FIG. 86 is an isometric view of the underside of the endoscopeguide member utilized in the FIG. 84 and 85 embodiments according toanother aspect of the invention illustrating its full lengthlongitudinal slit.

[0129]FIG. 87 is an isometric view of another embodiment of theinvention that accepts a conventional laparoscope, and permitsunobstructed visualization during laparoscopic surgical procedures asdescribed herein.

[0130]FIG. 88 is an isometric view of the tunneling member of the FIG.87 embodiment according to aspects of the present invention,illustrating a laparoscope inserted through the central bore of themember, and illustrating the features associated with the open endeddistal portion of the member.

[0131]FIG. 89 is an isometric view of the FIG. 87 embodiment thatillustrates the insertion of a conventional laparoscope into theapparatus to permit unobstructed laparoscopic viewing.

[0132]FIG. 90 is an isometric view of the FIG. 87 embodiment of theinvention in partial cut-away, with the balloon unrolled and laid flat.

[0133]FIG. 91 is an isometric view substantially similar to the FIG. 90view illustrating the insertion of a laparoscope into the apparatus topermit laparoscopic observation during both tunneling and balloonexpansion according to aspects of the present invention.

[0134]FIG. 92 is a cross-sectional view of the FIG. 87 apparatus,showing the sealing of the elongate balloon neck between the handle andan internal instrument body.

[0135]FIG. 93 is yet another embodiment of a laparoscopic apparatusaccording to the invention that provides for the insertion of aconventional laparoscope to permit viewing of laparoscopic procedures asdescribed herein.

[0136] In general, the apparatus of the present invention is Used forinsertion into a body to create an anatomic space. In one embodiment ofthe invention, the apparatus is comprised of a tubular introducer memberhaving a bore extending therethrough. A tunneling shaft is slidablymounted in the bore and has proximal and distal extremities including abullet-shaped tip. A rounded tunneling member is mounted on the distalextremity of the tunneling shaft. An inflatable balloon is provided.Means is provided on the balloon for removably securing the balloon tothe tunneling shaft. Means is also provided for forming a ballooninflation lumen for inflating the balloon. The balloon is wrapped on thetunneling shaft. A sleeve substantially encloses the balloon and iscarried by the tunneling shaft. The sleeve is provided with a weakenedregion extending longitudinally thereof, permitting the sleeve to beremoved whereby the balloon can be unwrapped and inflated so that itlies generally in a plane. The balloon as it is being inflated createsforces generally perpendicular to the plane of the balloon to causepulling apart of the tissue along a natural plane to provide theanatomic space.

[0137] More in particular, as shown in the drawings, the apparatus ordevice 31 for creating such an anatomic space for use in a laparoscopicprocedure (see FIG. 1) includes an introducer sleeve or device 32 whichconsists of a tubular member 33 formed of a suitable material such asplastic which is provided with a bore 34 extending throughout the lengththereof. A handle section 36 is mounted on one end of the tubular member33 and is also formed of a suitable material such as plastic. It isprovided with a bore 37 that is in communication with the bore 33. Aflapper valve 38 is mounted within the section 36 and is movable betweena position in which it closes off the bore 37 and position out of theway of the bore 37, by means of a finger operated actuator 39 mounted onthe exterior of the section 36. A stopcock 41 is mounted on the section36 and is in communication with the passage 37. A lever 42 is providedfor opening and closing the stopcock 41.

[0138] A tunneling shaft assembly 46 is slidably mounted in the bores 37and 34 of the introducer sleeve 32. The tunneling shaft assembly 46consists of a tunneling shaft or rod 47 formed of a suitable materialsuch as stainless steel, of a suitable length, as for example 18 inches,and a suitable diameter of approximately {fraction (1/8)} inch. Thetunneling rod 47 is provided with proximal and distal extremities 48 and49.

[0139] An introducer member 51 is slidably mounted on the tunnelingshaft or rod 47 and is formed of a suitable material such as plastic.The introducer member 51 is substantially hollow as shown and isprovided with a bore 52 through which the tunneling shaft 47 extends.The introducer member 51 is provided with a substantially hemisphericaltip 53 to form a rounded protrusion or first obturator through which therod 47 extends. The introducer member 51 has a length such that when itis introduced into the bore 34 of the introducer sleeve, it extends outof the distal extremity of the introducer sleeve 32, as shownparticularly in FIG. 1. This diameter of the introducer member 51 issized so that it can be slidably mounted in the bore 34. The other endof the introducer member 51 is provided with a chamfer 54.

[0140] A disk-type seal 43 having a central opening is provided in thesection 36 in alignment with the bore 37, and is adapted to permit theintroduction of the introducer member 51 therethrough.

[0141] The section 36 forms one part of a three-piece handle 56 of thelaparoscopic apparatus 31 which is sized so that it is adapted to begrasped by the human hand. As can be seen particularly in FIG. 4, thehandle 56 is generally rectangular in cross-section. The handle 56 isprovided with an intermediate section 57 which has a bore 58 extendingtherethrough in registration with the bore 37 and has the same generaldiameter as the bore 37 so that the introducer member 51 can traveltherethrough. The sections of the handle 56 can be characterized ashaving first, second and third sections, in which section 36 is thefirst section and intermediate section 57 is the second section.Latching means is provided for interconnecting the intermediate section57 to the end section 36, and consists of a pair of oppositely disposedlatches 61 pivotally mounted on the pins 62 in the intermediate section57. Each of the latches 61 is provided with a latch portion 63 adaptedto engage a protrusion 64 provided on the end section 36, and isyieldably urged into engagement therewith by a spring 66. Each of thelatches is provided with a cam surface 67 which is adapted to be engagedby the chamfer 54 of the introducer member 51 to cam the latch portion63 out of engagement with the protrusion 64 to release the intermediatesection 57 from the end section 36 for a purpose hereinafter described.

[0142] The handle 56 also consists of another end section 71, which canalso be characterized as the third section, which is secured to theproximal extremity of the tunneling shaft or rod 47. A pair of latches72 are provided in the end section 71 and are pivotally mounted on pins73. The latches 72 are provided with latch portions 74 adapted to engageprojections 76 provided in the intermediate section 57. Means isprovided for yieldably retaining the latches 72 in engagement with theprojections 76 and consists of a U-shaped spring 77 mounted within theend section 71 and engaging the latches 72. The latches 72 are providedwith knurled portions 72 a which extend outwardly which are adapted tobe grasped by the fingers of the hand so that the latch portions 74 canbe moved out of engagement with the projections 76 against the force ofthe spring 77.

[0143] The tunneling shaft assembly 46 also includes a tunneling memberor tip 79 which is mounted on the distal extremity of the tunnelingshaft or rod 47. As shown, the tip 79 is substantially olive-shaped andcan also be called a second obturator. It is provided with a roundedhemispherical surface on its distal extremity which has a maximumdiameter which is slightly less than the diameter of the bores 34 and 37so that it can pass through the introducer sleeve 32. The proximalextremity of the tip 79 is of smaller diameter to provide an annularstep 81 in the tip. The proximal extremity of the tip 79 is alsohemispherical, as shown. The tunneling member or tip 79 can be formed ofa suitable material such as plastic and can be secured to the distalextremity of the tunneling shaft or rod 47 by suitable means such as anadhesive. As hereinafter explained, the tunneling shaft or rod 47 ismovable so that the tip 79 can be brought into engagement with thehemispherical end 53 of the introducer member 51 for a purposehereinafter described.

[0144] The laparoscopic apparatus 31 also includes a balloon assembly 86which is shown in FIGS. 2, 5 and 6. As shown in FIG. 5, when the balloonassembly 86 consists of a balloon 87 which in plan, when deflated, has apear-shaped configuration. The balloon is preferably formed of anon-elastomeric, medical-grade material of a suitable type such as PVC.Thus, the balloon 87 can be formed of two sheets 88 and 89 of such amaterial which have their outer margins bonded together by suitablemeans such as by a heat seal 91 extending around tire perimeter of theflat balloon 87. The balloon 87 is provided with a neck 94 into which aflexible tubular member 96 extends, and is secured therein in a suitableairtight fashion such as by an adhesive. The tubular member 96 isprovided with a lumen 97 which is in communication with the interior ofthe balloon and which can be used for inflating the balloon through aLuer-type fitting 98 mounted on the free end of the tubular member 96.

[0145] Means is provided for removably securing the balloon 87 to thetunneling rod or shaft 47, and consists of a sleeve 101 formed of thesame material as the balloon 87, and which can be formed integral orseparate therefrom and adhered thereto by suitable means such as anadhesive. The sleeve 101 extends longitudinally of the balloon 87 and isdisposed generally equidistant from the side margins of the same. Thesleeve 101 is provided with a passage 102 extending therethrough whichis sized to slidably accommodate the tunneling shaft or rod 47. Means isprovided for permitting separation of the balloon 87 from the tunnelingrod by movement sidewise from the axis of the passage 102 and takes theform of longitudinally spaced apart perforations 103 in the sleeve 101extending longitudinally the length of the sleeve 101. The perforations103 are spaced close enough together to form a weakened region so thatthe balloon can be readily separated from the tunneling rod byseparating the plastic sleeve 101 by tearing the plastic between theperforations as hereinafter described.

[0146] As shown in FIG. 6, the sleeve 101 is disposed equidistant fromthe side margins of the balloon, permitting the balloon to be inflatedas hereinafter described and as also shown by the dotted lines in FIG.6, to be inflated around the rod 47. When deflated, the side margins ofthe balloon 87 can be rolled inwardly toward the rod 47 as shown by thebroken lines in FIG. 6 to permit the same to be folded into a generallycylindrical configuration as shown in FIG. 2, and to be enclosed withina removable sleeve 106 carried by the tunneling shaft or rod 47. Theremovable sleeve 106 is formed of a relatively thin-walled tubularmember 107 of a suitable material such as Teflon which has a weakenedregion 108 in its wall extending longitudinally the length thereof. Thisweakened region 108 can take the form of a slit as shown, or can be aseries of perforations or slots formed in the wall, or a combinationthereof. The proximal extremity of the tubular member 107 is providedwith split-apart or separable end portions 107 a and 107 b to which aresecured finger rings 109 of a suitable material such as plastic andsecured thereto by fasteners 111.

[0147] Operation and use of the laparoscopic apparatus in performing themethod for laparoscopic hernia repair through preperitoneal space maynow be briefly described as follows. Let it be assumed that thelaparoscopic apparatus 31 has been assembled as shown in FIG. 1. Asshown in FIG. 7, let it be assumed that a human patient 121 is in aprone position and has a hernia 122 in the lower abdominal area which hewishes to have repaired. The patient is prepared in an appropriatemanner by administering a suitable anesthesia, as for example a spinalanesthesia, and any other necessary preparation. The surgeon first makesan infraumbilical incision 126 in the skin below the navel or umbilicus127 and separates the fat 129 and then incises the anterior rectussheath or fascia 131 in the midline. Care should be taken not topenetrate the peritoneum overlying the abdominal cavity 133 (see FIG.8).

[0148] After the incision 126 has been made in the manner hereinbeforedescribed, the laparoscopic apparatus 31 is then taken by one hand ofthe surgeon, grasping the handle 56 and utilizing the other hand tofacilitate the insertion of the rounded blunt tip 79 into the incision126. The blunt tip 79 is caused to enter the slit in the fascia 131 andpass anterior to the peritoneum 132, in between the rectus muscles(laterally), and enters the potential preperitoneal space 136 to beprovided for the laparoscopic procedure. The blunt tip 79 is thenutilized as a tunneling device by the surgeon using one hand 56 toadvance the blunt end 79 toward the pubic region of the patient whilethe surgeon places his other hand on the abdomen to feel the apparatusor device 31 as it is being advanced. The advance of the device 31 iscontinued until the blunt tip 79 is below the symphysis pubis 137 asshown in FIG. 8, and preferably is disposed between the symphysis pubis137 and the bladder 138.

[0149] After the apparatus or device 31 has been properly positioned asshown in FIG. 8, the removable sleeve or sheath 106 is removed by thesurgeon using one hand to engage the finger rings 109 which are exteriorof the body of the patient and outside of the incision 126. At the sametime, the other hand of the surgeon is utilized to stabilize the portionof the device 31 which is within the preperitoneal space. The sheath 106can be readily withdrawn since it is formed of Teflon and is split orweakened along its length, by pulling it proximally and away from thelongitudinal axis of the tubular member 33. As the sheath 106 opens andslips off, it exposes the balloon 87 of the balloon assembly 86. Whenthe sheath 106 is completely removed, a sterile saline solution servingas a balloon inflation medium is introduced into the balloon 87 throughthe tubular member 96 by connecting a conventional syringe 141 to theLuer fitting 98. The balloon 87 typically can be inflated to a suitablesize by introducing 500 cc or less of normal saline solution into theballoon by pressing on the plunger 142. As the balloon 87 is inflated,the balloon progressively unwraps with its side margins rollingoutwardly from the center while expanding into a plane to causeprogressive separation or dissection of tissue (i.e. 131, 132) along itsweakest points by application of forces generally perpendicular to theplane of the balloon as indicated by the arrows 143 in FIGS. 6 and 9, tocreate the preperitoneal or anatomic space. The balloon 87 expandsaround the tunneling shaft 47 in the manner shown in broken lines inFIG. 6 to achieve the progressive separation until complete inflation isachieved. The surgeon can sense the filling of the balloon by feelingthe abdomen of the patient as the balloon is inflated. The balloon 87serves to open up the preperitoneal space 136 to provide a bloodlessspace for the procedures hereinafter to be performed. Since the balloonis formed of a non-elastomeric material, it is a volume-limited balloonto prevent overexpansion. Different sizes of balloons can be utilizedfor different patient sizes. With a smaller balloon it is possible todeflate the balloon and then shift the balloon and again reinflate it toobtain the desired bloodless preperitoneal space.

[0150] After the desired bloodless anatomic space or pocket 136 isformed, the balloon 87 is deflated by withdrawing the normal salinesolution by withdrawal of the plunger 142 of the syringe 141 or via ahospital vacuum aspirator. After the balloon 87 has been deflated, theballoon assembly 86 can be removed by grasping the handle 56 of thelaparoscopic apparatus or device 31 with one hand and using the otherhand to grasp the tubular member 96 and the proximal extremity of theballoon 87 and to remove the same through the incision 126, as shown inFIG. 10. As the balloon 87 is being removed, it is progressivelyseparated from the tunneling rod or shaft 47 by causing the sleeve 101to split apart along the longitudinal perforations 103 provided in thesleeve 101. This makes it possible to separate the balloon 87 from thetunneling rod 47 without the necessity of removing the tunneling rod 47or the introducer device 32.

[0151] After the balloon assembly 86 has been removed, the introducerdevice 32 can be advanced distally over the tunneling shaft or rod 47 soit extends well into the preperitoneal space 36 as shown in FIG. 11. Theend section 71 of the handle 56 is then removed by depressing thelatches 72 by having the fingers engage the portions 72 a to disengagethe latch portions 74 from the intermediate section 57 of the handle 56.The end section 71 is then drawn proximally as shown in FIG. 11 to bringthe olive-shaped tip 79 into engagement with the obturator 53 disposedin the distal extremity of the tubular member 33 to cause both the tip79 and the obturator 53 to be withdrawn or retracted. As the introducermember 51 is being withdrawn, its chamfer 54 will strike the camsurfaces 67 of the latches 61 to cause them to disengage from the endpiece 36 to carry it along with the introducer member 51 and shown inFIG. 2. Thus, it can be seen that the tunneling shaft assembly 46 can bereadily removed merely by one motion of the surgeon's hand. Thereafter,a conventional laparoscope 144 (see FIG. 16) can be introduced throughthe introducer sleeve 32 to permit the surgeon to view the preperitonealspace 136.

[0152] The dissected preperitoneal space 136 is then insufflated withcarbon dioxide through the stopcock 41 to a pressure ranging from 6 to 8mm of mercury. Thereafter, two additional trocars 146 and 147 areintroduced through the abdominal wall into the dissected preperitonealspace 136 in appropriate locations. Thus, as shown in FIG. 7, trocar 146is introduced into the left side of the abdomen of the patient below theintroducer sleeve 32 and the trocar 147 is introduced into the dissectedpreperitoneal space immediately above the symphysis pubis and directlybelow the introducer sleeve 32. As can be appreciated, the locations ofthe trocars 146 and 147 is generally dictated by the location of thehernia 122 to be repaired.

[0153] A patch 151 of the present invention to be utilized in the herniarepair procedure is shown in detail in FIGS. 12, 13 and 14. The patch151 can be characterized as a hernia patch or graft and is made of asuitable plastic mesh such as a Prolene mesh manufactured by Ethicon,Inc. The patch 151 can be of any desired configuration. For example itcan be generally circular as shown, and consists of a disk 152 of asuitable diameter, as for example 2 inches. A tail 153 is secured to thedisk substantially in the center thereof, in a suitable manner. Forexample, as shown, the tail 153 can be provided with split portions 153a and 153 b which are split apart and offset with respect to each other,which are secured to a smaller reinforcing disk 154 formed of the samematerial as disk 152 and secured to the disk 152 by suitable means suchas surgical thread (not shown). The tail 153 is formed of the samematerial as the disk 152 and 154, or it can be formed of a differentmaterial, such as Goretex. It can have a size such that it has a widthof approximately {fraction (1/2)} inch and a length of approximately{fraction (1/2)} inches. As shown particularly in FIG. 14, the sidemargins of the disk 152 can be rolled inwardly towards the centeradjacent the tail 153 to form a cylindrical roll 156 such as shown inFIG. 14 with the tail 153 extending outwardly therefrom. The roll 156can be maintained in its rolled-up condition by means of sutures 157disposed adjacent opposite ends of the roll and on opposite sides of thetail 153.

[0154] Conventional laparoscopic instruments are utilized which areintroduced through the trocars 146 and 147 while visualizing the samethrough the laparoscope 144 introduced through the introducer device 32to dissect the hernia 161 to permit visualization of its neck 162 as itis entering the internal inguinal ring 163. The hernia sac 161 isdissected from the surrounding tissue (spermatic duct and vessels) (seeFIG. 15). The process is facilitated by CO₂ pressure impinging on theneck of the hernia sac. As soon as this dissection is completed, theroll 156 is pushed into the trocar 147 and advanced through the same bysuitable means such as a deployment rod 164 (see FIG. 16) to enter thedissected preperitoneal space 13 as shown in FIG. 16. Alternatively, theroll 156 can be placed in a tubular member (not shown) which can be usedto position the roll 156 within the trocar 157. Thereafter, by thedeployment rod 164, the roll 156 can be pushed out of the tubular memberinto the dissected preperitoneal space 136.

[0155] The roll 156 after it is in the preperitoneal space is thenmanipulated so that its tail 153 is disposed alongside the neck 162 ofthe hernia sac 161 as shown in FIG. 17. A conventional stapling device166 is then introduced through the trocar 146 to staple the tail 153 tothe neck 162 by placing staples 167 therein. These staples 167 serve todivide the neck of the sac into distal and proximal portions 162 a and162 b. As soon as this stapling operation is completed, the two portions162 a and 162 b are separated from each other because of the pressure ofthe insufflation gas to cause the tail 153 of the patch 151 to be pulledupwardly into the inguinal ring to pull with it the disk 152. Thesutures 157 are cut apart to permit the disk 152 to unroll and to beplaced across the inguinal ring 163 which created the main weakness inthe abdominal wall permitting the hernia which is being repaired tooccur. The proximal portion 162 b of the neck 162 is stapled together bystaples 173 as shown in FIG. 18. The proximal portion 162 is thenpermitted to fold back into the desired anatomical location within theabdomen.

[0156] Thereafter, while observing the procedure under the laparoscope,the dissected preperitoneal space 136 can be deflated by permitting thecarbon dioxide gas to escape to the atmosphere through the stopcock 41in the introducer device 32 by operation of the stopcock lever arm 42.As deflation is taking place, the movement of the patch 151 is observedthrough the laparoscope 144 so that it does not become misplaced. Whenthe deflation has been completed, the patch 151 is in a position overthe inguinal ring 163 and serves to provide enforcement to prevent theoccurrence of another hernia in that area. The tail 153 is disposed withthe inguinal ring 163 and retains the mesh disk 152 so that it surroundsthe inguinal ring 163.

[0157] After deflation has been accomplished, the trocars 146 and 147 aswell as the introducer device 32 can be removed. Small sutures can thenbe utilized to close the various small openings which have been providedin the abdominal wall so that upon healing there will be minimalnoticeable scars from the procedure. The scar in the navel or umbilicustypically is almost nearly invisible.

[0158] It has been found that the use of the laparoscopic apparatus 31in accomplishing the method as hereinbefore set forth provides aprocedure in which the pain after the operation is markedly reduced.This is particularly true since the operation does not involve suturingof any ligaments which typically produces the pain. In addition, therecovery time for the patient is greatly accelerated. In the procedureof the present invention, a patient can return to work within a matterof 3 to 5 days rather than in a number of weeks as in a conventionalhernia repair procedure. The procedure also has other advantages. Forexample, there is a lack of necessity for a general anesthesia. Anotherprincipal advantage of the procedure is there is no contact of meshpatch 151 with the intestines of the patient or other intra-abdominalstructures, thus greatly reducing the possibility of adhesion formation.In addition, the graft which is formed by the patch 151 is more secureand is positioned in an anatomically correct position. This is becausethe hernia sac is in exact alignment with the hernia and pulls with itthe tail 153 of the graft to ensure that the graft formed by the patch151 is drawn into the correct position and is maintained in thatposition to prevent migration. In addition, the graft, by having anadditional central disk 154, ensures that additional reinforcement isprovided in the proper location in the center where the weakest regionin the abdominal wall has occurred. In addition, by such propercentering, the mesh construction of the patch 151 serves to uniformlyreinforce the area surrounding the hernia.

[0159] Another embodiment of the present invention is shown in FIGS. 20,21 and 22 with respect to another embodiment of a balloon assembly 181and another embodiment of a patch or graft 182. The balloon assembly 181consists of a balloon 186 formed of two sheets 187 and 188 which arerectangular in shape, as for example square as shown in FIG. 20, whichare heat-sealed together at their outer margins as indicated by thebroken line 189. A tubular member 191 is provided which has one endsealed into one corner of the balloon 186 as shown in FIG. 20. Thetubular member 191 is provided with a lumen 192 which opens up into theinterior space 193 of the balloon. The sheets 187, 188 are formed of anon-elastomeric material of the type hereinbefore described. A Luerfitting 194 is connected into the free end of the tubular member 191 andis utilized for introducing a saline solution into the balloon 186 forinflating the same.

[0160] The graft or patch 182 can have a desired configuration, as forexample circular as shown in FIG. 20. It is formed of a non-absorbablesynthetic surgical mesh, as for example from polypropylene manufacturedby Ethicon Inc. As shown, the mesh patch 182 overlies the sheet 187.

[0161] The balloon assembly 182 with the patch 182 thereon can berolled-up into a roll 196 as shown in FIG. 22 in which the patch orgraft 182 is disposed within the roll. The roll can be maintained in theroll configuration by sutures 197 wrapped about the same. The roll 196can then be introduced through a side trocar 146 and introduced into thedissected preperitoneal space 136 with the tubular member 191 extendingthrough the trocar 146 and having its Luer fitting 194 disposed outsideof the trocar. After the roll 196 has been introduced, the sutures 197can be removed and the balloon can be inflated by introducing a salinesolution through the fitting 194 by use of a syringe 199. Before thesaline solution is introduced to inflate the balloon, the roll 196 isproperly positioned so that when it is inflated and begins to unroll itwill unroll in the proper direction so that the graft or patch 182carried thereby is properly positioned as shown in FIG. 23. After theroll 196 has been completely unrolled, continued inflation of theballoon 186 moves the patch 182 so that it is pressed against theportion of the fascia through which the hernia has occurred as shown inFIG. 24. As soon as the graft 182 has been properly positioned, theballoon 186 is deflated. The trocar 146 is then removed, and thereafterthe balloon can be withdrawn through the opening in which the trocar waspresent. Thereafter, the gas utilized for insufflation can be permittedto discharge through another trocar so that the fascia 131 comes intoengagement with the peritoneum 132 with the large-area patch 182 held inplace therebetween. Thereafter, the trocars can be removed in the mannerhereinbefore described to complete the procedure.

[0162] Another embodiment of a balloon assembly for deploying alarge-area patch or graft through a trocar is shown in FIG. 25. Thelarge-area graft 201 shown in FIG. 25 is formed of a mesh material ofthe type hereinbefore described and has a generally oval-shapedconfiguration conforming to the general shape of the balloon 202 of theballoon assembly 203. The balloon 202 is constructed of anon-elastomeric material in the manner hereinbefore described. A tubularmember 206 is provided for inflating the balloon and has a Luer fitting207 on the free end thereof. Means is provided for retaining the meshgraft 201 on one side of the balloon and consists of plastic flaps 208provided on opposite sides of the balloon 202, and secured thereto by asuitable means such as a heat seal along the broken line 209. The innermargins of the flaps 208 are free and are adapted to receive the outermargins of the graft 201 as shown particularly in FIG. 25.

[0163] The balloon 202 with the mesh graft 201 thereon can be rolled-upinto a substantially cylindrical roll 211 by rolling the outer marginsof the balloon inwardly on top of the mesh material to provide two rolls211 and 212 which are brought in adjacent to each other as shown in FIG.26 with the mesh graft 201 being wrapped up therewith. The two rolls 211and 212 can then be inserted into a tubular sheath 214. The sheath 214can then be introduced through a trocar in a manner hereinbeforedescribed and then pushed out of the sheath into the abdominal cavity.The balloon can then be inflated with a saline solution to cause the tworolls 211 and 212 to unroll in opposite directions and then for theballoon to inflate to move the patch 201 carried thereby into engagementwith the portion of the fascia having the hernia therein. Thereafter,the balloon can be deflated, the trocar removed, the balloon removed,and the dissected preperitoneal space deflated so that the large meshgraft 201 is disposed between the fascia and the peritoneum and isretained in position therebetween.

[0164] Another embodiment of a graft which can be utilized in connectionwith the present invention is shown in FIG. 27. The patch or graft 216is constructed in a manner similar to the graft or patch 151 shown inFIGS. 12 and 13, with the exception that it is constructed in a mannerso that it can be utilized with a direct hernia rather than an indirectinguinal hernia hereinbefore described. The graft 216 is formed of asheet of circular mesh in the form of a disk 217 with a reinforcingcentral disk 218 which has a barbed head 219 secured thereto. The barbedhead 219 is formed of a biodegradable material such as polyglycolicacid. The mesh graft 216 can be folded over a deployment rod 221 andintroduced into a cylindrical sheath 222 (see FIG. 28) which is sized sothat it can be introduced through a conventional trocar, then deployedfrom the sheath 22 by pushing on the deployment rod 221. After the graft216 has been deployed into the dissected preperitoneal space 136, it canbe positioned in an appropriate manner so that the barb 219 ispositioned so that it is in alignment with the inguinal ring wherebyupon deflation of the preperitoneal space 136, the barb 219 will extendthrough the inguinal ring to serve to retain the graft 201 firmly inplace.

[0165] Another embodiment of a laparoscopic apparatus incorporating thepresent invention is laparoscopic apparatus 231 as shown in FIGS. 29through 32. The laparoscopic apparatus 231 includes introducer sleeve ordevice 32 identical to that hereinbefore described. It also includes atunneling shaft assembly 46 which is provided with a tunneling shaft orrod 47 and a proximal extremity 49 (see FIG. 32). In the previousembodiment of the laparoscopic apparatus, the tunneling shaft assemblyis provided with an olive-shaped or bullet-shaped tip 79 which wassecured to the distal extremity 49 of the tunneling shaft 47. In thepresent embodiment of the apparatus shown in FIGS. 29 through 32, theobturator tip 79 a is detachably mounted on the distal extremity 49 ofthe tunneling rod 47. The proximal extremity of the tip 79 a is providedwith a slot 236 which extends through one side of the proximal extremityinto the central portion of the proximal extremity of the tip 79 a. Theslot 236 is adapted to receive the rounded extremity 237 provided on thedistal extremity 49 of the tunneling rod 47 (see FIG. 32). A removablesleeve 241 is provided as a part of a laparoscopic apparatus 231, and issimilar in many respects to the removable sleeve or sheath 106hereinbefore described. The removable sleeve 241 is formed of a suitablematerial such as Teflon as hereinbefore described and is provided with atubular member 242 which is provided with a relatively thin wall 243that has a weakened portion extending longitudinally thereof in the formof a slit 244 (see FIG. 31). The tubular member 242 is provided with aproximal extremity 246 and a distal extremity 247. The proximalextremity 24 b has a thicker cross-section than the distal extremity247, as shown in FIGS. 31 and 32. The proximal extremity 246 is providedwith a recess 248 formed in the wall which is diametrically opposite theslit 244 that serves as a relief region to permit the movable sleeve 241to be split apart when it is removed from the balloon.

[0166] The proximal extremity 246 is provided with wing-like members 251and 252 which extend diametrically therefrom, spaced 90° apart from theslit 244. These outstretched wings 251 and 252 serve to help thephysician orient the laparoscopic apparatus 231 as it is being utilized.The proximal extremity 246 is also provided with a handle 256 which isformed integral therewith and which extends radially from the tubularmember 242. The handle 256 is provided with a finger hole 257 extendingtherethrough through which a finger can be inserted to facilitatepulling the removable sleeve 241 off of the balloon as described inconnection with the previous embodiment.

[0167] As shown in FIG. 33, the tip 79 a is detachably mounted in theproximal extremity of the removable sleeve 241 so that the tip 79 canserve as a second obturator during introduction of the laparoscopicapparatus 231 as hereinbefore described. Means is provided for securingthe detachable tip 79 a to prevent it from becoming separated from thelaparoscopic apparatus 231 and for permitting its withdrawal after thelaparoscopic procedure is being completed. As shown in FIGS. 33 and 34,such means consists of a flexible elongate element 261 in the form of abraided string formed of a suitable fabric such as Nylon, which has oneend 262 secured in a slot 263 provided on the distal extremity of thetip 79 a by suitable means such as an adhesive (not shown). The flexibleelongate element 261 extends from the distal extremity of the tip 79 ain a recess 264 opening through the external surfaces of the tip 79 a.The proximal extremity of the flexible elongate element 261 can besecured directly to the balloon 87 or, alternatively, it can extendthrough the perforated sleeve 101 provided in the balloon along thetunneling shaft so that it extends beyond the proximal extremity of thetunneling shaft.

[0168] The use of the laparoscopic apparatus 231 in performing alaparoscopic procedure is substantially identical to that hereinbeforedescribed with the exception that when the removable sleeve 241 isremoved from the balloon 87, the removable sleeve can be pushedforwardly to detach the tip 79 a from the tunneling shaft 47. Theremovable sleeve 241 then can be pulled rearwardly to separate it fromthe balloon along the slit 244. As soon as this occurs, the tip 79becomes free of the sleeve and begins to rotate in the direction of thearrow 266 shown in FIG. 34. When the balloon has been inflated and hasperformed its functions as hereinbefore described and it is now desiredto remove the balloon 87, the balloon 87 can be withdrawn in the mannerhereinbefore described, and since the tip 79 a is tethered to theballoon 87 itself or flexible elongate element 261 attached theretoextends out proximally of the balloon 87, the tip 79 a is withdrawn orcan be withdrawn with the balloon 87.

[0169] This laparoscopic apparatus 231 with its detachable obturator tip79 a will be useful in certain applications of the present invention.With the previous laparoscopic apparatus hereinbefore described, thereis a possibility that when the obturator tip 79 is withdrawn criticalstructures, as for example small arteries, may be inadvertently incisedbetween the tip 79 and the distal extremity of the tubular member 33 ofthe introducer device 32. This possibility is eliminated by having thedetachable tip 79 a, which is withdrawn when the balloon is withdrawn.

[0170] Still another embodiment of the laparoscopic apparatusincorporating the present invention is shown in FIGS. 36, 37 and 38, inwhich the laparoscopic apparatus 271 consists of a balloon 272 of thetype hereinbefore described, which is provided with a perforated sleeve273 through which the tunneling rod 47 extends. The distal extremity 274of the sleeve is closed by an end piece 276. The balloon 272 is wrappedin the manner hereinbefore described around the tunneling shaft 247. Thetunneling shaft or rod 47 is not provided with a tunneling member orsecond obturator of the type hereinbefore described but its end isrounded as shown by providing a rounded tip 47 a.

[0171] The wrapped balloon 272 is enclosed within a removable sleeve 281which is similar to those hereinbefore described. It is provided with atubular member 282 that has a weakened region in the form of a slit 283extending longitudinally the length thereof. The removable sleeve 281differs from those hereinbefore described in that rather than being openat the end as in previous embodiments, it is provided with a closed-end,bullet-shaped or olive-shaped tip 286. The slit 283 is provided with acurved portion 283 a which extends through the bullet-shaped tip 286 sothat the sleeve can be peeled off of the balloon 272 in the mannerhereinbefore described by pulling on the handle 288 having a finger hole289 therein. During the time that the removable sleeve 281 is beingpeeled off or separated from the balloon 272, the balloon is held inplace by the tunneling rod 47 which engages the end 276 of theperforated sleeve 273. The balloon 272 after it is inflated can beseparated from the tunneling rod 47 by pulling on the balloon andcausing its distal extremity to lift up and to break apart at theperforations and peel away from the rounded extremities 47 a of thetunneling shaft 47 as shown in FIG. 38. Continued pulling on the balloon272 will cause it to separate from the tunneling rod 47 so that theballoon 272 can be removed as hereinbefore described. Thus, it can beseen that there has been provided an embodiment of the laparoscopicapparatus of the present invention in which the need for an obturatorcarried by the distal extremity of the tunneling rod 47 has beeneliminated by providing the second obturator as a part of the removablesleeve 281. In all other respects, the operation and use of thelaparoscopic apparatus 271 is similar to that hereinbefore described.

[0172] From the foregoing it can be seen that there has been provided anapparatus and method for developing an anatomic space by the use of awrapped balloon which, as it is inflated, gradually unwraps to tend toform a plane to cause forces to be created perpendicular to the planefor pulling apart tissue along a natural plane to provide an anatomicspace, thereby providing a dissection in the weakest plane creating amore natural, less traumatic and bloodless region in which to performvarious medical procedures. Such anatomic spaces can be created invarious parts of the human body, for example in the preperitoneal areato provide a space anterior to the peritoneum for hernia repair and forvarocele dissection. Spaces can also be developed lateral to theperitoneum and spaces posterior to the peritoneum for performing medicalprocedures such as a sympathectomy and a lymph node dissection.

[0173] As hereinbefore explained, the apparatus and method isparticularly appropriate for performing laparoscopic hernia repair,permitting the use of grafts and patches which can be used for directand indirect hernias with minimal pain to the patient and with thepatient being able to return to work within a few days.

[0174] Another embodiment of a laparoscopic apparatus 301 incorporatingthe present invention is shown in FIGS. 39-48. The laparoscopicapparatus 301 can also be described as an assembly in the form of asurgical dissector with a cannula which serves as a hand manipulatedsurgical instrument that can be used during general surgicallaparoscopic procedures to dissect the layers of fascia between the skinand the peritoneum as described in conjunction with the previouslydisclosed embodiments of the invention. The laparoscopic apparatus 301consists of a cannula 302 with a tunneling device 303 mounted therein.The tunneling device 303 or guide rod 306 consists of a blunt obturatorand an introducer member 307. The laparoscopic apparatus also includes askin seal assembly 311, a balloon assembly 312 and a balloon coverassembly 316 as shown particularly in FIGS. 39 and 40.

[0175] The cannula 302 consists of a cannula tube 321 formed of a rigidplastic having proximal and distal extremities 322 and 323. A flowpassage 324 extends from the proximal extremity 322 to the distalextremity 323. A cannula housing or handle 326 is mounted on theproximal extremity by suitable means such by molding it directlythereon. As disclosed in copending application, Ser. No. 07/968,201,filed on Oct. 29, 1992, the disclosure of which is hereby incorporatedby reference in its entirety, the handle 326 includes first and secondvalve members (not shown) in which one valve member serves as aduck-bill valve and the other valve member serves as a circularinstrument or tool seal. The housing is provided with a Luer-typefitting 327 which is in communication with the interior of the housingoutside of the duck-bill valve and is in communication with the passage324 in the cannula tube 321.

[0176] As described in copending application, Ser. No. 07/968,201, filedon Oct. 29, 1992, the cannula 302 is adapted to receive the tunnelingdevice or blunt obturator device 303 which is generally of the typedescribed hereinbefore in the present application. This device 303consists of the blunt obturator 306 having a blunt tip 331 which isgenerally olive-shaped as-shown (see FIG. 41) and is formed of asuitable material such as plastic. The olive-shaped tip 331 is molded onthe distal extremity 332 of a rod or a shaft 333 formed of a suitablematerial such as stainless steel. The blunt tip 331 is sized so that itsoutside diameter is slightly less than the inside diameter of thecannula tube 321. The proximal extremity 334 of the rod or shaft 333 hasmounted thereon a handle part 336 of a handle assembly 337 whichincludes a second handle part 338. The handle parts 336 and 338 areadapted to mate with each other and are detachably connected in a mannerdescribed in copending application Ser. No. 07/968,201 filed Oct. 21,1992 by the use of latch means (not shown) adapted to be actuated byspring-operated latch members 339 disposed on opposite sides of thehandle part 336 and adapted to be engaged by the fingers of the handholding the handle assembly 337. The second handle part 338 forms a partof the introducer device 307 and is mounted on the proximal extremity341 of an introducer member 342 formed of a suitable material such asplastic. The introducer member 342 is provided with a distal extremity343 and has a bore 344 extending from the proximal extremity to thedistal extremity through an end surface 346 (see FIG. 41) which isinclined at a suitable angle, as for example approximately 45°proximally from the horizontal axis for the bore 344. The bore 344 issized so it can slidably receive the shaft 333.

[0177] The handle part 338 is provided with latch means (not shown)which is adapted to releasably connect the handle part 338 to thecannula housing 326 and includes latch members 349 disposed on oppositesides of the handle part 338 adapted to be engaged by the fingers of thehand holding the handle assembly 337 to permit the handle part 338 to beseparated from the cannula housing 326.

[0178] The skin seal assembly 311 generally can be of the type describedin copending application Ser. No. 08/124,333 filed Sep. 20, 1993, and asdescribed therein consists of a screw body 350 formed of a suitablematerial such as plastic having a helical thread 351 and a scallopedflange 352. A resilient insert 353 is disposed in the screw body 351 andis formed of a suitable resilient material such as silicone. The insert353 is provided with a bore 354 extending therethrough. A collet 357having slots 358 therein surrounds the insert 353 and is engaged by acollar 356 movable axially of the screw body 351 and is adapted to movethe collet to compress the insert 353 to move the insert between aretaining position for the cannula tube 321 extending through the bore354 to retain the cannula 302 in a desired longitudinal position withrespect to the skin seal assembly 311 and a releasing position in whichthe cannula 302 can be slidably moved longitudinally inwardly oroutwardly with respect to the skin seal 311. The collar 356 is providedwith an annular shoulder 359 having circumferentially spaced-apart slots360 therein which are used for a purpose hereinafter described. Asexplained in copending application Ser. No. 08/124,333 filed Sep. 20,1993, means is provided to restrain rotation of the collar 356 withrespect to the collet 357 and includes longitudinally extending keys 355spaced 180° apart.

[0179] The balloon assembly 312 consists of a balloon 361 formed of anon-elastomeric, medical grade plastic material of a suitable type suchas polyurethane. The balloon 361 can be characterized as having anasymmetric manta ray configuration when viewed in plan and is providedwith a forwardly extending rounded protuberance 362 which has a widthsubstantially less than that of the balloon 361. The balloon 361consists of two sheets of material which can be identified as a first orupper sheet 363 and a second or lower sheet 364 which have been die cutto the desired configuration with their edges bonded together in asuitable manner such as by means of a heat seal to form a balloon whichhas a generally flat configuration when deflated as shown in FIG. 40.The upper or outer surface of the first or upper sheet 363 has beenroughened in areas 365 as shown in FIG. 40 on the outwardly extendinglobe portions 361 a and 361 b for a purpose hereinafter described. Theroughening can be accomplished in any suitable manner such as byembossing the plastic material with a pattern having raised portionstherein.

[0180] Means is provided for inflating the balloon with a suitablemedium, as for example a liquid such as a saline solution and consistsof a flexible tube 366 that extends into the balloon between the twosheets 363 and 364 and forms a fluid-tight seal therewith. The interiorof the balloon can be inflated by introduction of the fluid through thetube 366. The tube 366 is connected to a Y-adapter 367 which has one legof the Y connected to a one-way valve 368 having a Luer fitting and theother leg connected to a tube 369 which is connected to a taperedfitting 371. A conventional pinch off clamp 372 is mounted on the tube369. The tube 366 is adapted to be releasably retained in the slots 360of the shoulder 359.

[0181] Means is provided for removably securing the balloon 361 to thetunneling rod or shaft 306 and consists of an elongate tubular member orsleeve 376 which extends along the length of the balloon 361 and isdisposed on one side of the balloon 361 which can be called the top sidegenerally centrally of the balloon 361. The tubular member 376 isprovided with a passage 377 therein through which the tunneling or guiderod or shaft 333 extends. As hereinbefore explained, this tubular memberor sleeve 376 can be formed as a separate member which is bonded to thetop sheet 363 or alternatively can be formed integral with the top sheet363 with two heat seals being provided above and below to form thesleeve 376 with the passage 377 therein. The tubular member 376 can beprovided with spaced-apart elongate slits or perforations (not shown)extending along a line 378 in the tubular member 376 to facilitateseparation of the balloon from the tunneling rod 333 as hereinafterdescribed. With a such a construction it can be seen that the tunnelingrod or blunt dissector or obturator 306 overlies the balloon 361 foradvantageous features hereinafter described.

[0182] The balloon cover assembly 316 consists of a semi-rigid tube 381formed of a suitable material such as plastic and is provided withproximal and distal extremities 382 and 383. It is provided with a bore384 (see FIG. 42) which extends from the proximal extremity 382 to thedistal extremity 383. The tube 381 is provided with a weakened region inthe form of a partial slit 386 extending from the distal extremity 383to the proximal extremity 382 of the tube 381 on the bottom side of thetube 381 as viewed in FIG. 40 (also see FIG. 42). The tube 381 isprovided with a proximal end wall 387 which extends at a suitable angle,as for example 45° proximally with respect to the axis of the, bore 384.

[0183] The balloon cover assembly 316 also includes a handle 391 whichas shown can be formed as a separate part and is secured to the proximalextremity 382 of the tube 381 by a metal clip 392. The handle 391 isprovided with a tapered body 393 formed of a suitable material such asplastic which as shown in FIGS. 42 and 47 is open on the bottom side tomake accessible a longitudinally extending recess 394 which issemi-circular in cross-section. A pair of sideways extending wings 396are formed integral with the body 393 and lie in a plane which issubstantially coincident with the axis of the semi-circular recess 394.As shown, the wings 396 are disposed at the proximal extremity of thebody 393.

[0184] An upwardly extending fin 397 is formed on the body 393substantially equidistant from the wings 396 in a direction generallyperpendicular to the plane in which the wings 396 lie. The fin 397 isrelatively narrow and is provided with an upper surface 378 havingnotches 401 and 402 therein. A vertically extending wall 406 is formedas a part of the fin 397 and extends generally in a direction which isperpendicular to the plane of the wings 396. The wall 406 extends in adirection at right angles to the fin 397 and has a gradually increasingthickness from the top to the bottom ends of the wall (see FIG. 46). Thebody 393 is provided with a pair of spaced-apart holes 407 spacedapproximately 90° apart and 450 from each side of the fin 397. Anelongate slot 408 is formed in the body 393 and is generally inalignment with the fin 397. A pair of camming slots 411 are provided onopposite sides of the body 393 in the wings 396 adjacent the distalextremities of the wings adjacent the body. The camming slots 411 areprovided with inclined camming surfaces 412.

[0185] The body 393 is provided with a pair of diametrically disposedprotrusions 413 which extend into the recess 394 and which are adaptedto seat in a pair of diametrically opposed holes 414 provided in thedistal extremity of the introducer member 342.

[0186] The balloon cover assembly 316 also includes a clamping member416 which is provided with a central body 417 and a pair of downwardlyextending legs 418 and 419 (see FIG. 43) which extend downwardly intothe camming slots 411. As shown, the central body 417 is disposed justdistal of the fin 397 and is provided with semi-circular guides 421formed integral with the central body 417 and disposed on opposite sidesof the fin 397 in a fulcrum region which is just slightly above thepoint of commencement of the legs 418 and 419. The central body 417 isprovided with longitudinally extending reinforcing ribs 422 (see FIGS.43 and 45). It is also provided with a proximally extending latchportion 426 which extends generally at right angles to the central body417. The latch portion 426 is provided with a centrally disposed slot427 extending substantially the entire length thereof which receives theupper extremity of the fin 397 so that when the clamping member 416 issnapped into placed over the body 393, the latch portion 426 is disposedin the notch 401 and cannot clear the uppermost portion of the fin 397.The clamping member 416 as hereinafter described is adapted to be movedbetween positions in which it is disposed within the notch 401 oralternatively in the notch 402. Laterally extending rounded raisedportions 428 are provided on the central body 417 are adapted to beengaged by a finger of the hand when moving the clamping member 416 fromthe notch 401 to the notch 402.

[0187] Operation and use of the surgical balloon dissection apparatus301 in performing the method for developing an anatomic space forlaparoscopic hernia repair in connection with the apparatus shown inFIGS. 39-48 may now be briefly described as follows in conjunction withthe cartoons which are shown in FIG. 49a through FIG. 49g. The surgeonin connection with the present method identifies the appropriate fascialayer to be dissected, either by direct visualization of the tissueand/or by manual palpation. Let it be assumed that it is desired toperform a hernia repair on a patient 451 and that it is desired tocreate an extraperitoneal working space for performing the surgicalrepair. The surgeon makes a small incision 452 in the skin of thepatient in the umbilicus or slightly lateral of the umbilicus. Aretractor (not shown) can then be utilized to open up the incision andto move it laterally to either side to locate the rectus muscles thatrun longitudinally of the body of the patient on both sides of theumbilicus or navel. As soon as the rectus sheath has been located, theincision is made in the rectus sheath through the incision previouslymade midway between the two sets of the rectus muscles. The surgeon thengrasps the laparoscopic or balloon dissection apparatus 301 by using ahand, as for example his right hand as shown in FIG. 49A to grasp thehandle assembly 337 to introduce the blunt end 331 into the incision toengage the anterior wall of the posterior rectus sheath. The balloondissector 301 is then advanced longitudinally of the patient's bodygenerally parallel to the two sets of rectus muscles as shown by thearrow 453 by using the rectus sheath as a guide to pass the blunt tip331 to cause separation of tissue and to pass over the arcuate line andtransversalis fascia to the level of the symphysis pubis. This can bereadily accomplished with the balloon dissector 301 because the ballooncover assembly 316 is latched to and generally rigidly connected to thedistal extremity of the introducer member 342 of the introducer device307 by having the protrusions 413 provided on the tubular cover 381seated within the holes 414 provided on the distal extremity of theintroducer member 342. This provides a rigid assembly of the balloondissector 301 so it can be operated by the surgeon grasping the handleassembly 337 without the need to have the physician grasp by the otherhand an intermediate part of the balloon dissector to cause a desiredmanipulation and steering of the blunt tip 331 as the dissection of thetissue is accomplished as it is advanced.

[0188] The travel of the blunt tip 331 to the level of the symphysispubis can be readily ascertained by the surgeon who can use his hand topalpate the abdominal region of the patient and thereby feel the blunttip 331 as it is advanced until the blunt tip 331 strikes the symphysispubis. This can be readily ascertained by the right hand holding thehandle assembly 337 feeling the impact of the tip 331 striking thesymphysis pubis 468 (see FIG. 50) which impact is communicated throughthe rigid structure of the balloon dissector to the handle assembly 337where it can be felt by the hand of the surgeon. The balloon dissector301 is then advanced a small additional amount so that the blunt tip 331drops below the symphysis pubis 468.

[0189] Thereafter, the balloon cover handle 391 is engaged by the sameright hand of the physician as shown in FIG. 49B and the thumb is usedto engage the transverse rounded protrusions 428 by moving the upperextremity of the clamping or latching member 416 proximally to cause thelatch portion 426 to move into engagement with the notch 402 carried bythe fin 397. As this is occurring, the legs 418 and 419 carried by thecentral body 417 are moved from the position shown in FIG. 42 to theposition shown in FIG. 47 and in doing so engaging the camming surfaces412 whereby the portions of the wings 396 secured to the body 393 arecammed outwardly so that the protrusions 413 are moved out of engagementwith the holes 414. The direction of movement of the latch or clampingmember 416 is indicated by the arrow 454 in FIG. 49B. As soon as thehandle 391 has been released, the handle 391 is moved proximally withtwo fingers of the hand grasping the wings 396 to pull them upwardly andproximally to cause the balloon cover assembly 316 to be removed. Theballoon 361 is held in place by the tunneling shaft or rod 336 and exitsthrough the slit 386 provided at the bottom of the tubular cover 381which serves as a tear away sheath. The balloon inflation tube 366 isretained in one of the slots 360 in the shoulders 359 so that it doesnot become entangled in the wings 396 as the balloon cover assembly 316is removed. This exposes the balloon 361 which has its side marginsrolled inwardly in rolls 461 with one being rolled in a counterclockwisedirection and the other being rolled in a clockwise direction so thatthey underlie the tunneling rod 333 as shown in FIG. 50. Also to provideoptimum dissection as hereinafter described before the rolling up occursthe forwardly extending protuberance 362 can be folded inwardly along afold line 471 and the sidewardly extending lobe portions also can befolded inwardly along fold lines 472. To inflate the balloon the pinchoff clamp 372 is closed and a conventional 60 cc syringe 476 containinga saline solution is connected to the one-way valve 368. The syringe 466is then operated as shown by the arrow 477 to introduce the salinesolution from the syringe 476 into the tubular member 366 and into theinterior of the balloon 361 to gradually inflate the same. The one-waycheck valve 368 ensures that saline solution cannot exit therefrom whenthe syringe 466 is removed. The syringe 476 after it has been emptiedcan be removed and refilled with a saline solution which is introducedinto the balloon in the same manner to cause the side margins of theballoon 461 to unwrap in opposite directions as shown in FIG. 50 onopposite sides of the tunneling rod 333 until they become completelyunwrapped. Typically, it may take as many as approximately ten syringesof saline solution to cause the balloon 361 to completely unwrap and themove into an inflated condition as shown in FIG. 50. As the balloon isbeing filled and unwrapping, it continues to separate or dissect tissueoverlying the peritoneum to provide an extraperitoneal working spacebetween the transversalis fascia and the rectus muscles.

[0190] As hereinbefore described, the balloon 361 in plan has anasymmetric manta ray-like configuration to provide the desired optimumextraperitoneal working space for the hernia repair. The forwardlyextending protrusion 362 provided on the balloon 361 as it is inflateddissects distally from the distal extremity of the blunt tip 331 of theguide rod 333 serves to provide good dissection of tissue in the area ofCooper's ligaments and also to dissect laterally around the inguinalrings. By utilizing an asymmetric manta ray-like construction, it ispossible to provide a balloon 361 with its wide side margins or lobeportions 361 a and 361 b which when inflated to cause forward movementof the balloon 361 to dissect downwardly around the inguinal rings andto wedge the balloon 361 in place. The forwardly extending protrusion362 as it is inflated dissects like a small balloon down to the Cooper'sligament. In this way, it is possible to obtain an extraperitonealworking space 478 which exposes all the desired anatomy at one timebefore moving off to the hernia sac and to do the final dissection forthe hernia repair. By providing such a large extraperitoneal workingspace it is unnecessary to manually advance the dissection. The balloonhas also been shaped to properly match the anatomy in which theprocedure is to be formed so as to reduce to a minimum the amount ofmanual dissection which may be needed. Since the balloon has aparticular shape and is formed of a non-elastomeric material, thedissection will occur in the desired locations which would notnecessarily be the case if the balloon were formed of an elastomericmaterial which generally would have a tendency to follow the path ofleast resistance. Additional assurance is provided for ensuring thatdissection will occur in the desired locations with the non-elastomericballoon of the present invention because the balloon is held in place bythe tunneling rod 333 underlying the symphysis pubis 468 as shown inFIG. 50. Also by providing roughened areas 365 these areas frictionallyengage overlying tissue so that the lobe portions 361 a and 361 b canserve as anchors to prevent displacement of the balloon 361 after theballoon 361 as it is being inflated.

[0191] After the amount of desired tissue dissection has taken place byinflation of the balloon 361 to provide the extraperitoneal workingspace, the balloon 361 is deflated by connecting the evacuation fitting371 into an evacuation port (not shown) of an operating room suctionsystem. The pinch clamp 372 is released to open the tube 369 to permitthe saline solution which had been introduced into the balloons 361 tobe sucked out to completely deflate the balloon from the inflatedcondition as shown in FIG. 49C.

[0192] After the balloon has been deflated, the tubular member 366 canbe grasped by the fingers of the hand as shown and the deflated balloon361 pulled out through the incision 452 in the direction as shown by thearrow 481 in FIG. 49D. If necessary, the handle assembly 337 can be heldby the other hand. The balloon 361 as it is being pulled off has itssleeve 376 separates from the tunneling or guide rod 331 by breakingthrough the linear perforations lying along the line 378. The guide rod331 remains in place to preserve an easy entry into the extraperitonealspace which has been created. The balloon 361 can then be discarded.

[0193] After the balloon 361 has been removed, the left hand is used tograsp the lower second handle part 38 with the left hand while the righthand engages the upper or first handle part 336 of the handle assembly337. The fingers of the right hand then engage the latch members 339 onopposite sides by the fingers of the hand to release the first part 336from the second part 338 and to permit the left hand to move the secondpart 338 in the direction of the arrow 482 shown in FIG. 49E. The secondpart 338 carries with it the cannula 302 attached thereto and theintroducer device 307 which extends therethrough with the skin sealassembly 311 mounted on the cannula tube 321. This advancement over theguide rod 333 is continued until the distal extremity 343 of theintroducer member 342 has been advanced into the desired position. Assoon as this has been accomplished, the skin seal assembly 311 isslidably advanced on the cannula tube 321 until the skin seal approachesthe incision 452. The screw body 351 is then rotated by the fingers ofthe hand engaging the flange 352 and/or to the shoulder 359 to screw itinto the incision 452 and to form a gas tight skin seal with the skin ofthe patient. As soon as a good skin seal has been established, theintroducer device 307 is clamped in a fixed position with respect to theskin seal assembly 311 by pushing generally downwardly on the collar 356to engage the collet 357 to form a friction grip between the elastomericinsert 353 and the cannula tube 321.

[0194] After the cannula 302 is in a fixed in position, the bluntobturator 306 can be removed along with the tunneling device or bluntobturator device 303. This is accomplished merely by continuing to pullupwardly on the handle part 336 with the hand in the direction indicatedby the arrow 483 as shown in FIG. 49F. As this pulling motion continues,the blunt tip 331 will engage the distal extremity 343 of the introducermember 342 causing a withdrawal force to be applied to the second handlepart 338 to cause it to automatically release from the housing 326. Thispermits the blunt obturator device 303 to be removed through the cannulatube 321. This is possible because the blunt tip 331 has a diameterwhich can pass through the interior of the cannula tube 321 and throughthe valving provided in the housing 326. In withdrawing the guide rod333 carrying the obturator tip 331, it can be seen that it continues tobe guided by the introducer member 342 and thus will remain centeredwith respect to the cannula tube 321 to avoid any pinching action at thedistal end 323 of the cannula tube 321. As soon as the obturator tip 331strikes the introducer member 342, the handle part 338 is automaticallydisengaged from the cannula handle 326. The latch parts 349 aresubstantially buried within the second handle part 338 so they arerelatively inaccessible to the surgeon ensuring that he will operate thelatch parts 339 carried by the first handle 336 which helps to ensurethat the surgeon remove the handle parts 336 and 338 in two stages.

[0195] After this has been accomplished a source of gas such as carbondioxide is connected to the stop cock valve 328. The stop cock valve 328is opened to permit the carbon dioxide to inflate the dissectedextraperitoneal working space such as indicated by the dotted lines 476shown in FIG. 49G. The cannula 302 can then be utilized for introducinginstruments of various types into the dissected extraperitoneal workingspace. The inflation gas cannot escape because of the valving providedin the handle 326 of the cannula 302.

[0196] Additional cannulae can be introduced in various positions in theabdomen of the patient through which additional surgical instruments canbe introduced for performing the surgical procedure to be performed inthe extraperitoneal working space. The remainder of the hernia repairprocedure to be accomplished in the extraperitoneal working space issubstantially the same as hereinbefore described and therefore will notbe described in detail. By way of example, let it be assumed that ahernia sac has been formed in the patient, as for example by passingdown into the scrotum to form a typical indirect hernia. The hernia saccan be pulled out and ligated in a manner hereinbefore described.Thereafter, a piece of mesh as hereinbefore described can be introducedthrough another site and rolled out over the region through which thesac had previously passed. The mesh can then be stapled in place, as forexample along the Cooper's ligament. After the hernia repair has beencompleted, the extraperitoneal working space can be deflated by openingthe stop cock valve 328 and bleeding the CO₂ contained therein toatmosphere to permit the abdominal wall to return to its normal positionto help retain the mesh which has been placed in the desired position.

[0197] In connection with the formation of the extraperitoneal workingspace with the apparatus of the present invention, it has been foundthat it is desirable to have the guide rod 333 be in position in whichit overlies the balloon 361 because this helps to ensure that theballoon dissection will occur in appropriate areas because the blunt tip331 underlying the symphysis pubis is retained in the desired positioneven during the time that the balloon is unrolling during inflation.Positioning the guide rod 333 in this manner, ensures that the balloon361 will roll out in the opposite directions from the rod and also tohelp to push the balloon downwardly during inflation.

[0198] In order to make the apparatus more user friendly, the partswhich are to be moved for operation with respect to other parts havebeen color coded, as for example they can be colored black with theremaining parts being of another color, such as grey or white. Thus, theclamping or latch member 416 is of a black color because it must beremoved to unlatch the balloon cover assembly 316. Similarly, the collar356 of the skin seal assembly 311 is of a black color because it must bemoved to clamp the cannula 302 in a desired position. Similarly, thelatch parts 339 and 349 are of black color because they also must bemoved to separate the handle parts.

[0199] The wings 396 are provided on the balloon cover 316 in additionto serving as means to facilitate grasping of the balloon cover assembly316 when it is desired to remove the same, as serve to indicate theplane in which the balloon 361 of the balloon dissection apparatus 301causes dissection. Generally this dissection plane is in a plane whichis parallel to the plane in which the wings 396 lie.

[0200] As hereinbefore explained, the introducer member 342 is providedwith an obturator end surface or tip which is inclined at an angle in adirection away from the normal direction of insertion to inhibit anytendency that the tip might hang up on tissue as it is being advancedthrough the tissue during dissection.

[0201] The sizing of the blunt obturator tip 331 so it is smaller thanthe inner diameter of the cannula tube 321 helps to ensure that tissuewill not become entrapped or pinched between the tip 331 and the cannulatube 321. In addition, as hereinbefore described, the obturator tip 331is tapered in both directions into a smaller dimension from the centerto also minimize the possibility of any tissue being entrapped betweenthe tip 331 and the cannula tube 321 and thereby ensuring that ashearing action will not occur.

[0202] In conjunction with the foregoing disclosure, it has been assumedthat the balloon dissection apparatus hereinbefore described typicallywould be disposed of after each use. In the event it is desired toeconomize and it is desired to reutilize at least certain portions ofthe balloon dissection apparatus after a use in a laparoscopicprocedure, another embodiment of a balloon dilatation apparatus 501incorporating the present invention is shown in FIGS. 51-55. As showntherein it consists of a handle assembly 502 similar to the handleassembly 337 hereinbefore described which includes a handle part 503similar to the handle part 336. Other parts of the balloon dissectionapparatus 501 are not shown because they can be identical to thosehereinbefore described. The handle part 503 is provided with twosections 506 and 507 which can be fastened together in a suitable mannersuch as by ultrasonic bonding or an adhesive. Latch members 511 and 512are provided on opposite sides of the handle part 503 and are providedwith finger portions 513 that are adapted to be engaged by fingers ofthe hand which extend outwardly through recesses 514 in the sections 506and 507. The latch members 511 and 512 are each provided with a latch516 which is yieldably urged in an outward direction by a yieldablespring member 517 engaging a downwardly depending lip 518 providedwithin the sections 506 and 507. The latch members 511 and 512 arepivotally mounted between the sections 506 and 507 by pivot pins 519formed integrally on the latch members 511 and 512 and extending intobosses 521 provided in the sections 506 and 107 which are formed of asuitable material such as plastic.

[0203] First and second inserts 526 and 527 formed of a suitablematerial such as plastic are mounted in the sections 506 and 507. Firstand second latch members 531 and 532 formed of a suitable material suchas metal are provided which are seated in recesses 533 and 534 providedin the insets 526 and 527. The latch members 531 and 532 are generallyU-shaped and are yieldably urged into engagement with each other to forman elongate slot 536 extending therethrough. Upstanding legs 538 formedintegral with the inserts 526 and 527 are provided in rectangular spaces539 in the inserts 526 and 527 so that the upper extremities of the legs538 can be flexed by movement of the latch members 531 and 532 as shownby dotted lines in FIG. 54.

[0204] A guide rod 541 is provided which is similar to the guide rod 333with the exception that its distal extremity 542 is also provided withan annular recess 533. The distal extremity 542 is provided with achamfer 544 and a pair of opposed flats 546 which extend through thechamfer 544. The guide rod 541 extends through a hole 551 provided bysemicircular recesses formed in the sections 506 and 507 and by a hole552 formed by semicircular recesses in the inserts 526 and 527. A largerhole 553 formed by semicircular recesses in the inserts 526 and 527 of alarger diameter than the hole 552 is provided which receives apush-button 556 and extends through a hole 557 also formed bysemicircular recesses provided in the sections 506 and 507. Adish-shaped or concave recess 558 is provided in the sections 506 and507 and facilitates engaging the push-button 556 by a finger of thehand.

[0205] The push button 556 is provided with a bore 561 which is sized sothat it can receive the distal extremity 542 of the guide rod 541. Thepush button is provided with sideways extending skirts 562 extending180° with respect to each other and which are provided with distally andinwardly extending camming surfaces 563 which terminate at a tip 564that is generally V-shaped as shown in FIG. 51. The tip 564 is formed sothat it is adapted to enter into the slot 536 formed by the U-shapedmembers 531 and 532. Thus, when the push button 556 is depressed, thetip 564 will enter the slot 536 in a progressive manner to urge themapart so that the camming surfaces 563 carried thereby engage theU-shaped latch members 531 and 532 in regions just above and below theguide rod 541 so that the guide rod 541 is released by the U-shapedlatch members 531 and 532 permitting it to be pulled out of the handlepart 503. Release of the guide rod 541 makes it possible to separate theguide rod 541 from the remainder of the balloon dissection apparatus 501so that the handle assembly 502 and the other parts carried thereby canbe separated from the guide rod. Thereafter, the guide rod 541, theballoon 361 and the balloon cover assembly 316 can be disposed of. Theother parts of the apparatus can be reutilized after appropriatesterilization. In order to ensure that the other parts survivesterilization, it may be desirable to form the plastic reusable parts ofa suitable plastic such as a polysulfone.

[0206] Still another embodiment of the laparoscopic apparatusincorporating the present invention is shown in FIGS. 56-62. Thelaparoscopic apparatus 600 consists of an introducer device 601. Theintroducer device consists of a elongate tubular member or cannula 602formed of a suitable transparent medical grade plastic which is providedwith proximal and distal extremities 603 and 604 with a bore 606extending from the proximal extremity 603 to the distal extremity 604. Avalve housing 611 is mounted on the proximal extremity 603 of thetubular member 602 and is provided with a valve construction 612 of thetype disclosed in copending application, Ser. No. 08/124,283 filed Sep.20, 1993. The valve housing 611 and the valve 612 provided therein canaccommodate relatively large diameter devices which are adapted to beintroduced through the bore 606 of the tubular member 602 and form aseal with respect thereto.

[0207] An inflatable balloon 616 is provided which is formed of a sheet617 (see FIG. 69) of a non-elastomeric plastic material of a medicalgrade such as PET-E. The sheet 617 is provided with a weakened region618 extending transversely of the sheet, as for example by providingspaced-apart perforations in the sheet 617 (see FIG. 60). The sheet 617as shown in FIG. 60 is folded over onto itself to provide two portions617 a and 617 b with a fold line 619 being formed parallel to but spacedfrom the perforations 618 by a suitable distance, as for exampleone-quarter of an inch. A linear heat seal 621 extends across the sheet617 and bonds the two portions 617 a and 617 b to each other along aline parallel to but spaced apart from the fold line 619 and also fromthe perforations 618 by a suitable distance, as for examplethree-quarters of an inch. This three-quarter inch dimension isdependent upon the size of the balloon to be formed as hereinafterdescribed. The sheet 617 is cut adjacent its outer margins along thedotted line 622 to provide the balloon with the desired conformation asfor example the manta ray type shape hereinbefore described having arounded distal extremity.

[0208] After the heat seal 621 has been formed, the sheet 617 can beslit along the fold line 619 by suitable means such as a knife toprovide two additional portions 617 c and 617 d formed from the sheet617. Thus, by use of the heat seal 621 there are provided two portions617 a and 617 b which can be in a plane and two additional portions 617c and 617 d that extend transversely and outwardly of the plane formedby portions 617 a and 617 b (see FIG. 62). Also, these portions 617a-617 d can be described as forming an X with the portions 617 a and 617b forming the top side of the inflatable balloon assembly 616.

[0209] Thereafter, the portions 617 a and 617 b are unfolded so thatthey lie in a plane. They are then placed over another precut sheet 623(see FIG. 62) of the same non-elastomeric material as the sheet 617 anda suitable seal, as for example a heat seal 624 formed around the entireouter perimeters of the sheet 623 to bond it to the outer perimeter ofthe portions 617 a and 617 b to form a fluid-tight enclosure to providea space 626 within the balloon 627.

[0210] In order to make it possible to inflate the balloon 627 with aninflation medium, as for example with a saline solution, one end of acentral portion of the balloon 627 adjacent the portions 617 c and 617 dis mounted in an annular recess 628 provided on the distal extremity 604of the tubular member 602 (see FIG. 56) is bonded thereto in such amanner such as by an adhesive tape 629 to form a fluid-tight connectionbetween the distal extremity 604 of the tubular member 602 and the space626 within the balloon 627. Alternatively, a tube clamp of the typehereinafter described can be used. The balloon 627 is provided with arounded protuberance 631 to provide the desired configuration for thedissected anatomic space to be created by the balloon 627 and also toaid in the positioning of the balloon 627 during placement of theballoon in tissue in the body.

[0211] After the heat seal 624 has been completed, the outer sidemargins 632 and 633 of the balloon 627 are rolled inwardly anddownwardly in opposite directions towards the heat seal 621 to form tworolls 636 and 637 which are immediately adjacent to each other andgenerally underlie the heat seal 621. The two flaps or portions 617 cand 617 d are then brought downwardly as shown in FIG. 63 so that theyenclose the rolls 636 and 637 and are bonded together in a suitablemanner such as by a heat seal 641 extending transversely of the portions617 c and 617 d to form an enclosure or cover 642 for the compact rolls636 and 637. The perforations 618 are within the confines of the coveror enclosure 642 formed for the rolls 636 and 637 within the heat seal641 so that the cover or enclosure 642 for the rolls can be madeoperable or in other words slit along the weakened region along theperforations 618 to release the rolls 636 and 637 as hereinafterdescribed. From the construction hereinbefore described it can be seenthat the balloon 627 forms a part of the inflatable balloon assembly 616and is mounted on the distal extremity of the tubular member 602.

[0212] Means is provided for inflating the balloon 627 and consists of aLuer-type fitting 646 which is provided on the housing 611 and opensinto the interior of the housing 611 below the valve 612 in the housing611 so that it is in communication with the bore 606 and with theinterior space 626 within the balloon 627. The fitting 646 is connectedby flexible tubing 648 to a male fitting 649 which can be connected to asuitable fluid source, as for example a syringe (not shown) containing asaline solution to be utilized for filling the balloon. A tubing clamp652 of a conventional type is provided on the tubing 648.

[0213] A pair of diametrically extending wings 656 and 657 (see FIG. 58)are formed integral with the housing 611 and lie in a plane which isparallel to the planes in which the two halves of the balloon 627 lie.As hereinafter described, these wings 656 and 658 serve as means forascertaining the orientation of the balloon 627 during dissection ashereinafter described. The wings 656 and 657 are sized so that they areadapted to be engaged by the fingers of the human hand.

[0214] Means is provided for introducing an insufflation gas into theanatomic space as it is being dissected and during the time thelaparoscopic apparatus 600 is being utilized. This means consists of atubular member 661 which is provided with a lumen 662 (see FIG. 63)extending between the proximal and distal extremities 663 and 664 of thetubular member 661. The tubular member 661 can be secured to the balloon627 by suitable means such as an adhesive and has its distal extremity664 extending into the region of the rounded protuberance 631. Theproximal extremity 661 is secured to a Luer-type fitting 666 and isadapted to be connected to a source of insufflation gas.

[0215] A skin seal 671 having a helical thread 672 formed thereon has acone shaped configuration in which the cone increases in diameter fromthe distal extremity towards the proximal extremity. The skin seal 671is of the type disclosed in copending application, Ser. No. 08/124,333filed Sep. 20, 1993 and has a slip-friction fit on the exterior surfaceof the tubular member 602, the skin seal 671 has an axially adjustablecollar 674 which can be moved into clamping engagement with the tubularmember 602. The skin seal 671 is provided with a large bore 673 so thatit can accommodate various sized cannulae ranging in size from 10-15millimeters in diameter. The skin seal 671 is also provided with aconventional retaining mechanism for retaining a cannula insertedtherethrough at the desired depth.

[0216] The skin seal 671 has a longer length than is typical because inaddition to serving as a skin seal, it is utilized to preserve access tothe dissected space. In other words, it serves as a guide for directingother cannulae into the dissected space.

[0217] The laparoscopic apparatus 600 also includes a tunneling shaftassembly 676 (see FIG. 57) which consists of a tubular member 677 havinga bore 678 extending therethrough. The tubular member 677 is formed of atransparent medical grade plastic and is provided with an outer diameterwhich is adapted to fit within the skin seal 671. It can have a suitablelength such as 15-30 centimeters.

[0218] The tunneling shaft assembly 676 also consists of a closed bluntrounded tip 681 formed integral with the tubular member 677. The tip 681is also formed of the same transparent medical grade plastic as thetubular member 677. The tip 681 is provided with a conical recess 682 ofa depth so that the wall thickness is the same as that of the tubularmember 677. It should be appreciated that if desired, the tip 681 can beformed as a separate part from the tubular member 677 and securedthereto by suitable means such as an adhesive. The conical recess 682 issized so that it can receive the distal extremity of a laparoscope ashereinafter described.

[0219] Operation of the laparoscopic apparatus 600 shown in FIGS. 56-63may now be briefly described as follows. Let it be assumed that thelaparoscopic apparatus 600 is ready to be utilized by a physician in alaparoscopic procedure to perform a hernia repair. Typically, theintroducer device 602 with the balloon assembly 616 would be shipped bythe manufacturer along with the skin seal 671 and the tunneling shaftassembly 676. The tunneling shaft assembly 676 has a bore 678 that canreadily accommodate a conventional 10 millimeter laparoscope 686. Theconventional laparoscope 686 is provided with a shaft 687, an eyepiece688 and a fitting 689 for introducing light. Such a laparoscope 686 isinserted into the bore 678 down into the bore 682 in the tip 681 of thetunneling shaft assembly 676. A baffle 683 (see FIG. 57A) is mounted inthe bore 682 of the tip 681 and extends laterally and axially thereof.The baffle 683 is formed of a suitable material such as plastic and issecured to the tunneling shaft assembly 676 in a suitable manner such asby an adhesive (not shown). The baffle 683 is preferably formed of asuitable opaque material such as a black plastic. Alternatively, it canbe provided with a reflective surface away from the lens of thelaparoscope. Thus the baffle serves to keep reflective light away fromthe lens of the laparoscope to improve the viewing capabilities of thelaparoscope without interference from unwanted reflections, asrepresented by the ray 689, to provide a glare-free view by thelaparoscope. The baffle 683 is provided where the viewing lens for thelaparoscope 687 is disposed in one semicircular quadrant. Where theviewing lens for the laparoscope is in the center, a cylindricalproximally extending opaque baffle 691 (see FIG. 57B) is mounted in thetip 681 and circumscribes the lens to screen out unwanted reflections inthe field of view for the laparoscope to provide a glare-free view bythe laparoscope.

[0220] The tunneling shaft assembly 676 is then taken and its tip 681introduced through the valve housing 611 and into the bore 606 of theintroducer device 602 and thence into the balloon assembly 616 mountedthereon until the tip 681 is in disposed in the rounded protuberance 631of the balloon 627 with the tunneling shaft assembly 676 disposed in theballoon 637. The tubular member 677 of the tunneling shaft assembly 676provides the desired rigidity for the balloon 637 so that it can beintroduced into an incision made in the appropriate location, as forexample in the umbilicus as described in conjunction with the previousembodiments.

[0221] The tunneling shaft assembly 676 with the balloon carried therebyis then advanced into the tissue in the manner hereinbefore described inconnection with previous embodiments with the progress being observedthrough the laparoscope 686. The laparoscope 686 makes it possible toview the progress of the tip 681 and the various tissues beingencountered, since the tip 681 and the balloon 627 are transparent.

[0222] Immediately prior to inflation of the balloon 627, the wings 656and 657 are oriented so they lie in a plane which corresponds to theplane in which it is desired to have the balloon 627 carry out thedissection. Thus it can be seen that the wings 656 and 657 help toensure that the dissection occurs in the appropriate plane.

[0223] As soon as the tip 681 of the tunneling shaft assembly 676 islocated in the desired position, a saline solution can be introducedthrough the fitting 649 and into the bore 606 directly into the space626 in the balloon 627 to cause inflation of the balloon. As the balloon627 begins to inflate, the balloon 627 breaks the cover 642 by causingseparation along the perforations 618. This permits the rolls 636 and637 of the balloon 627 to evert outwardly and gradually unroll andprogressively inflate in two opposite lateral directions in the sameplane to cause dissection of the tissue in a natural plane ashereinbefore described in connection with the previous embodiments.During the time this dissection is taking place, the dissection can beviewed through the laparoscope 686 to visualize anatomic landmarks. Thevisualization through the laparoscope 686 is quite effective because theindex or refraction of the saline solution is near to that of theballoon material so there is very little reflection compared to asituation in which a visualization is attempted to be accomplished whenthe dissection balloon is filled with air.

[0224] Also during the time the balloon is inflated, it is possible toinsert the additional accessory trocars to be utilized during thelaparoscopic procedure into the dissected space to visualize theirentrance into the dissected space and to aid in proper positioning ofthe trocars.

[0225] After inflation of the balloon 327 and the desired dissection hasbeen accomplished, the skin seal 671 can be slid down on the tubularmember 602 into the incision and screwed into the incision to form asubstantially gas-tight seal therewith.

[0226] In connection with the present apparatus during the time thatdissection is being accomplished, it is possible to pass an insufflationgas into the space as it is being dissected. This can be accomplished byintroducing a suitable gas, as for example CO₂ through the tubularmember 661 through the fitting 666. This will provide some inflateddissected space outside the balloon in the vicinity of the tip 681 toaid in visualization of the anatomic space being created.

[0227] Let it now be assumed that the desired dissection has beenaccomplished and it is desired to remove the balloon assembly 616. Theskin seal 671 can be inserted before or after inflation of the balloon627. The skin seal 671 can be inserted by exerting a sliding androtating motion to the skin seal 671 on the tubular member 602 to causethe distal extremity of the skin seal 671 to progressively enter theincision until a substantially fluid-tight seal is formed between theskin of the patient at the incision and the skin seal 671. Thereafterthe introducer 601 can be grasped by holding the skin seal 671stationary in one hand and the housing 611 of the introducer 601 withthe other hand and pulling the introducer 602 outwardly from the skinseal and pulling with it the laparoscope 686 if it has not beenpreviously removed, the tunneling shaft assembly 676 followed by theballoon assembly 616 secured to the end of the introducer device 601.

[0228] Thus, it can be seen that the introducer device 601 and theballoon assembly 616 can be removed through the enlarged bore 673provided in the skin seal 671. As soon as this has been accomplished, aconventional trocar cannula can be introduced into the skin seal andclamped into the skin seal at the desired depth by operation of thecollar 674 in the manner described in copending application Ser. No.08/124,333 filed Sep. 20, 1993. Thereafter, insufflation of the anatomicspace can be accomplished by introducing a gas through the trocar andthereafter the laparoscopic procedure can be completed in the mannerhereinbefore described in connection with the previous embodiments.

[0229] In connection with the foregoing, it can be seen that by makingminor changes in the construction it is possible to save a great numberof parts of the balloon dissection apparatus for reuse aftersterilization. Only the parts which are most difficult to clean aredisposed of after a one-time use.

[0230] From the foregoing it can be seen that there has been provided anapparatus and method which is particularly suitable for developing ananatomic space such as an extraperitoneal working space between theabdominal wall and the peritoneum by dissecting tissue with the use of anon-elastomeric balloon. The balloon dissection apparatus has manyfeatures facilitating its use in developing such an anatomic space andfor particularly developing an extraperitoneal working space for herniarepair.

[0231] In connection with the present embodiment of the invention it canbe seen that visualization is possible through a laparoscope during theentire dissection procedure. The laparoscopic procedure has also beensimplified that it is unnecessary to remove a balloon cover as in theprevious embodiments. In the present embodiment of the invention, theballoon can be introduced without a balloon cover and can be inflatedalmost immediately. It also can be readily removed after the desireddissection has been completed by pulling the balloon out through theskin seal and thereafter inserting the trocar cannula. The presentinvention makes it possible to preserve access to the dissected spacewithout the need of retaining a obturator in location as with theprevious embodiments.

[0232] In FIG. 64, there is shown a cross-sectional view of the balloon627 laterally disposed inwardly extending folded portions 627 a and 627b. Thus, in effect the balloon 627 is double-folded inwardly in alateral direction before it is wrapped up and both sides formed intorolls and in the manner hereinbefore described and as shown particularlyin FIG. 63. In addition, the rounded protuberance 631 can also be foldedinwardly in a similar manner before the balloon is rolled-up and sealedbetween the portion 617 c and 617 d by the heat seal 641. This balloon627 is folded in the manner shown in FIG. 64 and then wrapped as shownin FIG. 63 and can be utilized in the same manner as the embodimenthereinbefore described. Upon inflation of the space 26 within theballoon, the balloon begins to inflate in an up and down directionrather than laterally until sufficient pressure is created within theballoon to cause the inverted bifolds 627 a and 627 b to begin to evertoutwardly to aid in forcing the balloon to unroll. This everting actionof the balloon facilitates unrolling of the balloon and aids indissection of tissue. This everting motion also avoids dragging theballoon across the tissue as it fills. When folded in the manner shownin FIG. 64, the balloon unfurls from within and progressively laysitself out on the dissected tissue as it inflates. Similarly, therounded protuberance 631 will evert and also unfold in a similar mannerto create dissection in a forward direction.

[0233] It should be appreciated that with the lateral bifolds providedin the balloon 627 the tubular member 677 can be inside or outside theballoon and still be provided with the broad bi-folds in the balloon627.

[0234] In connection with the present invention it has been found thatin certain surgical procedures there is a need to dissect around anobstruction as for example a hernia. For this purpose, ahorseshoe-shaped or bifurcated balloon 701 is provided as shown in FIGS.65-68. The balloon 701 is substantially Y-shaped as shown in FIG. 68 andis provided with a bifurcation 702 which leads into two legs 703 and 704to provide a U-shaped space 706 therebetween. The balloon 701 can beconstructed in the manner hereinbefore described for the previousballoons used in accordance with the present invention.

[0235] The legs 703 and 704 can be inverted into the bifurcation 702 asshown in FIG. 66 and then can be rolled into two rolls rolled in fromopposite sides onto an olive-tipped guide rod 711 shown in FIG. 65 andheld in place by a separate balloon cover (not shown) or by the use offlaps forming a sleeve such as shown in FIG. 59 to provide an assembly712. It has been found that in connection with the present invention toachieve the best dissection capabilities for the balloon and expansionof the balloon, the balloon 701 is secured to the guide rod or tunnelingrod 711 so that the guide rod underlies the balloons. The side marginsare rolled inwardly into two rolls so that the two rolls face downwardlytoward the tunneling guide rod 711. They are then brought into closeproximity with each other to form a single roll and secured to thetunneling guide rod 711 as hereinbefore described. A tubular member 713providing a balloon inflation lumen opening into the interior of theballoon 701 is sealed into the balloon 701. A Y adapter 714 is securedto the tubular member 713 and carries a male fitting 716 and anothertubular member 717 on which there is mounted a tubing clamp 718 andanother male fitting 719.

[0236] Let it be assumed that it is desired to dissect around anobstruction 720 which by way of example can be ventral hernia or otherobstruction that cannot be readily dissected. Let it also be assumedthat the assembly 712 shown in FIG. 65 has been introduced intodissected space in the manner hereinbefore described with or without thelaparoscope and an obstruction 720 is encountered and it is desired todissect around the obstruction 720. This can be accomplished by removingthe cover or sleeve (not shown) that was used for enclosing the balloonand securing it to the guide rod 711. As soon as the balloon 701 isreleased, it can be inflated through the tubular member 713 to unrollsideways or laterally in a plane just proximal of the obstruction 720.The balloon 701, because of the manner in which it was rolled-up, willunroll downwardly and outwardly away from the tunneling guide rod 711 tocreate the desired dissection. Continued inflation of the balloon willcause one or both the legs 703 and 704 to progressively evert andadvance around the obstruction 720. Thus, as shown in FIG. 67, the arm704 everts and passes around one side of the obstruction 720 whileaccomplishing dissection as it goes, whereas the other arm 703 canthereafter or simultaneously evert to cause dissection around the otherside of the obstruction 720 until both of the legs 703 and 704 arecompletely inflated to create a dissection extending around theobstruction 720. The balloon 701 can then be deflated and removedthrough the skin seal in the manner hereinbefore described. Insufflationand other surgical procedures in connection with the present inventioncan thereafter be performed.

[0237] Where it is desired to utilize a smaller cannula and skin seal, aconstruction and method such as that shown in FIG. 69 can be utilized.The laparoscopic apparatus 21 shown in FIG. 69 for use for such apurpose consists of a manta ray-shaped balloon 722 of the typehereinbefore described which is provided with sides or wings 723 and724. The balloon 772 is provided with a neck 726 through which a tubularmember 731 of the type hereinbefore described is serving as a scopecover. The neck of the balloon is secured to the tubular member 731 bysuitable means such as a hose clamp 732 of a conventional type. The tubeclamp can be formed of a suitable material such as plastic and can be ofthe type manufactured by Tyton Corporation, 7930 North Faulkner Road,Milwaukee, Wis. 53223. The tubular member 731 extends through a skinseal 736 of the type hereinbefore described which is provided with anaxially movable ring or collar 737. In order to be able to insert thelaparoscopic apparatus 721 into an incision, the wings or sides 723 and724 can be rolled inwardly and secured to the distal extremity of thetubular member 731 by suitable means such as a balloon cover (not shown)of the type hereinbefore described or, alternatively, by providing twoadditional flaps on the balloon of the type hereinbefore described whichcan be utilized for securing the rolled balloon to the tubular member.

[0238] A tubular member 741 is sealed within the balloon 722 and carriesa balloon inflation lumen (not shown) which is in communication with theinterior of the balloon 722 through its open end and through a pluralityof longitudinally spaced apart holes 745 in communication with theballoon inflation lumen. Tubular member 741 carries a Y fitting 742 thatcarries a male adapter 743. Tubing 74 is connected to the Y adapter 742and has mounted thereon another male fitting 746 and a hose clamp 747,all of the type hereinbefore described.

[0239] Operation and use of the laparoscopic apparatus 721 as shown inFIG. 69 may now be briefly described as follows. As in the previousembodiments, the distal extremity of the apparatus 721 can be insertedthrough a cannula or a trocar sleeve 733. As hereinbefore explained, thedistal extremity of the apparatus can be advanced by the use of thetubular member 731 as an obturator to advance the balloon to the desiredspace. As hereinbefore explained, this procedure can be viewed through alaparoscope (not shown) inserted into the tubular member 731 permittingviewing through the distal extremity of the transparent tubular member731 and the transparent balloon 722. After the desired amount ofdissection has been accomplished to induce the balloon 722 into thedesired location, the balloon cover if utilized can be removed.Thereafter, the balloon 722 can be inflated by introducing a salinesolution through the male fitting 743 and through the tubular member 741to cause it to unroll in two opposite directions to cause additionaldissection of the tissue to create an anatomic space below the skin ofthe patient. The balloon is retained on the tubular member or scopecover 731 by the clamp 732 during the time that inflation of the balloonis taking place.

[0240] After the desired amount of dissection has taken place byinflation of the balloon 722, the balloon 722 can be deflated by openingup the clamp 747 and permitting the fluid, as for example the salinesolution, to exit through the male adapter 746. As soon as the balloon722 has been deflated, the clamp 732 can be removed by pressing sidewayson the clamp 732.

[0241] The cannula 733 can then be advanced on the scope cover 731 topush the proximal extremity 726 of the balloon 722 through the incisionand so that the cannula 733 extends through the incision. The skin seal736 is advanced on the cannula into the incision to push off of thedistal extremity of the cannula 733. Then, while holding the cannula 733and the skin seal 736 in place, the tubular member or scope cover 731can be retracted and is completely removed from the balloon 722. As soonas the scope cover 731 has been removed, the deflated balloon 722 can bewithdrawn through the incision 752 by pulling on the tubular member 741.As soon as the balloon 722 has been removed, the skin seal 736 can berotated to complete insertion of the skin seal to form a fluid-tightseal between the skin 751 and the skin seal 736. Thereafter, theanatomic space which has been formed by dissection of tissue by the useof the balloon 722 can be insufflated in the manner hereinbeforedescribed and the desired surgical procedures performed.

[0242] Another embodiment of a laparoscopic apparatus 756 incorporatingthe present invention is shown in FIG. 70, which is substantiallyidentical to that shown in FIG. 69 with the exception that the balloon722 at the distal extremity of the balloon has been folded inwardly ontoitself onto the distal extremity of the scope cover 731 as shown by thefold 757. Operation and use of this embodiment is substantiallyidentical to that hereinbefore described in connection with theembodiment shown in FIG. 69. Upon introduction of an inflating fluidthrough the tubular member 741, the balloon will expand by evertingoutwardly to move the fold 757 in the balloon after which the balloonwill unroll sidewise in a manner similar to the balloon 722 ashereinbefore described in FIG. 69 to assume the dotted-line shape shownin FIG. 70. Thereafter, the balloon 722 can be deflated and removed inthe manner hereinbefore described in connection with FIG. 69.

[0243] A laparoscopic apparatus 761 incorporating another embodiment ofthe invention is shown in FIGS. 71 through 73 and as shown thereinconsists of a balloon 762 which as shown can have a manta ray shape ofthe type hereinbefore described. It is provided with a narrowed downneck 763 which is adapted to engage an annular taper 764 (see FIG. 73)carried by the distal extremity of a cannula 766. The cannula 766 can besubstantially identical to the cannulae hereinbefore described with theexception that it is provided with an inwardly extending annular taper764 which can be engaged by the neck of the balloon. The neck of theballoon is held in a fluid tight seal with respect to the taper by atubular member 771 which is provided with a bore 772 extendingtherethrough and which is sized so that it is adapted to receive aconventional laparoscope 773 of the type hereinbefore described. Thetubular member 771 is provided with an outer tapered distal extremity776 which is adapted to mate with the inner annular taper 764 providedon the cannula 766 and to retain the neck 763 of the balloon in aposition so as to form a fluid-tight seal to retain the balloon on thecannula 766 during and after inflation as hereinafter described. Thistapered distal extremity can be formed in a suitable manner such as by acollar 777 formed separately or as an integral part of the tubularmember 771 and having a slightly greater outer diameter than the outerdiameter of the tubular member 771 and is spaced a short distance fromthe distal extremity of the tubular member 771. This space has disposedtherein an resilient epoxy-like material 778 having an inwardly andforwardly extending taper of decreasing diameter in a direction towardsthe distal extremity of the tubular member 771. This material 778 has ataper which is similar to the taper provided on the inwardly extendingannular taper 764 on the cannula 776 so that when the tubular member 771is pushed inwardly in a distal direction, the tubular member will engagethe neck 763 of the balloon and frictionally hold it in place and at thesame time frictionally retain the tubular member 771 therein.

[0244] In the event there is difficulty in seating the neck of theballoon within the taper 774, the distal extremity of the laparoscope773 can be inserted through the bore 772 of the tubular member 771 andextended a slight distance into the balloon 762 beyond the neck of theballoon. The neck 763 of the balloon 762 can then be wrapped about thelaparoscope and the neck of the balloon with the laparoscope can bepushed inwardly with the tubular member 771 being retracted out of theway from the taper 764. As soon as the neck 763 is seated over the innertaper 764, the tubular member 771 can be pushed distally to frictionallyengage the neck of the balloon to firmly clamp it in place to form asealing engagement between the balloon 762 and the cannula 766.Thereafter if desired, the laparoscope 773 can be retracted.

[0245] There are many portions of the apparatus 761 which are verysimilar to that hereinbefore described. Thus, a skin seal 784 isslidably mounted on the cannula 766 and carries an axially movablecollar 782 of the type hereinbefore described for frictionally retainingthe skin seal 784 in a predetermined axial position on the cannula 771.A valve housing 786 is mounted on the proximal extremity of the cannula771 and carries an inlet port 787. A handle 788 of the type hereinbeforedescribed is detachably mounted on the valve housing 786 and carrieswith it the tubular member 771. Another valve housing 791 is mounted onthe handle 788 and is provided with a valve (not shown) to form a fluidtight seal with respect to the outer surface of the tubular member 771.The laparoscope 773 extends through the tubular member 771 which extendsthrough the valve housing 771 and also through the valve housing 786.

[0246] In the laparoscopic apparatus 771, an additional port is providedin the balloon 762 for inflating the balloon and consists of a tubularmember 796 which extends into the balloon and is sealed in the balloon.It is provided with an open end and a plurality of spaced-apart holes797 which open into the bore in the tubular member 796 and can beutilized for inflating the interior of the balloon 722 in a mannerhereinbefore described. A fitting assembly 799 is mounted on the tubularmember 796 and consists of a wye 801 mounted on tubular member 796. Thewye 801 has one leg of the Y connected to an adapter 802 and has theother leg of the Y connected to a tube 803 having a tubing clamp 804mounted thereon and connected to another male connector 806 of the typehereinbefore described.

[0247] Operation and use of the laparoscopic apparatus shown in FIGS.71-73 may now be briefly described as follows. Let it be assumed thatthe apparatus has been shipped in the manner shown in FIGS. 71-73 withthe neck 763 of the balloon retained against the taper 764 by thetubular member 771. As hereinbefore described, the balloon 762 can bewrapped up into a roll and enclosed within a removable balloon cover(not shown) or alternatively it can be enclosed by an integral ballooncover of the type hereinbefore described so that the balloon roll withthe balloon cover can serve as an obturator. If necessary, the balloonroll and cover combination can be aided by the distal extremity of thelaparoscope 773 extending to the distal extremity of the balloon 762 tocause the balloon roll and cover to pass through the incision and dosufficient dissection of tissue so that the balloon is disposed belowthe skin of the patient.

[0248] The balloon cover, if one is present, can then be removed and theballoon 762 inflated by introducing a saline solution through theadapter 102 by use of a syringe or other suitable means. As soon as theballoon is inflated and has been unrolled to create the dissection ashereinbefore described, the balloon can be deflated by permitting thesaline solution to pass through male adapter 806 upon opening of thetubing clamp 804. The cannula 766 can then be pushed through theincision into the anatomic working space which has been created by theballoon 762. The laparoscope 773 can then be removed. Thereafter thehandle 788 can be released to bring with it the tubular member 771 withthe tapered distal extremity 776 to release the neck 763 of the balloon762. Thereafter the fitting assembly 799 can be grasped and the balloon762 can be withdrawn through the incision outside the cannula 766. Afterthe balloon has been retracted, the skin seal 781 can be advanced intothe incision to form a fluid tight seal with respect to the skin of thepatient.

[0249] From the foregoing, it can be seen that with the laparoscopicapparatus 761 shown, the laparoscope 773 can be utilized duringinsertion of the balloon into the incision and during the time that theballoon is being inflated to dissect tissue. However, it should beappreciated that if it is unnecessary to view this procedure, thelaparoscope 773 can be eliminated, because in most instances the wrappedup balloon has sufficient rigidity to serve as an obturator to permitthe balloon to be pushed through the incision and to create adequatedissection below the skin of the patient to permit entry of the balloonafter which the balloon can be inflated as hereinbefore described.

[0250] The laparoscopic apparatus 761 and the method for utilizing thesame has the advantage that the balloon 762 can be retracted without thenecessity of pushing the same forwardly or distally of the cannula 766before removal.

[0251] Still another laparoscopic apparatus 811 incorporating anotherembodiment of the present invention is shown in FIG. 74 which in manyrespects is similar to the laparoscopic apparatus 761 shown in FIGS.71-73. Thus, it also includes the balloon 762 which is provided with aneck 763 seated against the inwardly extending taper 764 of the cannula766. The cannula 766 is provided with the valve housing 786 and thehandle 788. The valve housing 791 can be omitted because of the closedend on the tubular member 816.

[0252] The tubular member 816 has a smaller diameter portion 816 a atthe distal extremity and a larger diameter portion 816 b at the proximalextremity with an annular taper 817 adjoining the two portions 816 a and816 b and which is adapted to mate with the inwardly extending annulartaper 764 provided on the cannula 766 so that the neck 763 of theballoon 762 can be sealingly engaged therebetween in the same manner aswith the tubular member 771 to permit inflation of the balloon in thesame manner as hereinbefore described for the apparatus 761 shown inFIGS. 71-73. However, since the tubular member 816 has a closed roundedend, the inflation medium provided in the balloon cannot escape throughthe tubular member 816 and for that reason there is no need for theadditional sealing valve 791 provided in the embodiment of thelaparoscopic apparatus 761. The tubular member 816 serves as a scopecover as in a number of the previous embodiments of laparoscopicapparatus incorporating the present invention. It can be formed of atransparent material so that viewing can be accomplished through thesame and through the balloon 762 in the manner hereinbefore described.

[0253] Operation and use of the laparoscopic apparatus 811 is verysimilar to that hereinbefore described in conjunction with the apparatus761 shown in FIGS. 71-73. The proximal extremity or neck 763 can beintroduced on to the tapered surface 764 by wrapping it on to thetubular member 816 and drawing the neck 763 into the cannula 766 andthen advancing the cannula 766 distally so that the annular taper 817engages the neck of the balloon 762 and urges it into sealing engagementwith the inwardly extending taper 764.

[0254] With the balloon 762 rolled-up in the manner hereinbeforedescribed, the balloon 762 can be introduced with the use of the tubularmember 816 as an introducer through the incision in the skin of thepatient and thereafter it can be utilized to dissect tissue to place theballoon in the dissected tissue so that thereafter it can be inflated inthe manner hereinbefore described. After the balloon has been deflatedafter completion of the dissection, the balloon can be removed bypushing the cannula 766 into the incision and then releasing the neck ofthe balloon 762 by removing the tubular member 816. Thereafter, theballoon 762 can be removed by pulling on the fitting assembly 799 toremove the balloon 762 through the incision outside the cannula 766.After the balloon 762 has been removed, the skin seal 781 can beadvanced on the cannula into the incision to form a fluid tight sealwith the skin of the patient. Thereafter, insufflation can be undertakenfollowed by the desired surgical procedures as hereinbefore described.

[0255] In connection with the embodiments of the invention shown inFIGS. 69 and 74, it should be appreciated that the balloon 722 can haveits proximal extremity pushed forwardly through the incision 752 so thatit can be removed outside of the skin seal rather than retracting itthrough the skin seal as in previous embodiments to make possible theuse of a smaller cannula and skin seal. This can be accomplished in anumber of ways, as for example by utilizing the cannula to push theproximal extremity of the balloon through the incision or,alternatively, to utilize the skin seal to push the proximal extremitythrough the incision. Alternatively, the scope cover 731 can be pushedin a distal direction to engage the distal extremity of the balloon toin effect pull the balloon forwardly through the incision 752. Also,alternatively, if desired, the balloon can be again partially inflatedafter the collar 732 has been released to permit the proximal extremityof the balloon to be pulled inwardly through the incision 752.

[0256] Yet another embodiment of the laparoscopic apparatus of theinvention that may be used in conjunction with a conventionallaparoendoscope to provide for laparoscopic visualization duringlaparoscopic procedures as described herein is illustrated in FIGS.75-82. Laparoscopic apparatus 849 differs from previous embodiments ofthe invention that provide for laparoscopic visualization duringtunneling and dissection in several ways as will be explained below.Initially, it is to be noted that unlike previous embodiments, theapparatus 849 does not include a cannula and skin seal assembly as partof the obturator/balloon assembly 850. In this embodiment, the cannulaand skin seal are supplied as separate units.

[0257] In FIG. 75 laparoscopic apparatus 849 is shown assembled andloaded over the shaft 870 of a conventional laparoscope 862. Thelaparoscope has an eyepiece 863, and a fiber optic light port 897 topermit visualization of images at its distal end. In a presentlypreferred embodiment, the apparatus 849 has an elongated U-shapedchannel guide 853 (see FIGS. 78A-C) into which a preferably transparentand substantially rigid tunneling member 851 (see FIGS. 79 and 80)formed of a suitable material, such as polycarbonate, is preferablyinserted through an instrument seal (884 in FIG. 82). The tunnelingmember 851 serves a dual purpose. First, it functions as a scope coverinto which laparoscope 862 may be inserted for visualization duringtunneling and subsequent dissection. Second, together with the balloon855 and preferably an integral balloon cover 892, it functions as ablunt tipped obturator. The U-shaped channel guide 853 is substantiallyrigid and is preferably formed of a suitable medical grade of plastic.As illustrated in FIG. 78B vertical slots 885 may be cut in the distalend 872 of the channel guide 853 should some flexibility of the distalend 872 be deemed necessary or desirable.

[0258] Turning briefly to FIGS. 77 and 81, the presently preferredtransparent non-elastomeric balloon 855 may be formed from die cutsheets of an appropriate medical grade non-elastomeric plastic material,for example, and is sealed together along welds 869 such as by heatsealing. The balloon 855 is preferably provided with flaps 868 a and 868b (FIG. 77) which are joined together, as shown at 869 b. The right andleft balloon wings 891 may be rolled-up, as shown in FIG. 81, so as toform balloon rolls 890. The flaps 869 a and 869 b may then be wrappedaround the balloon rolls 890 and sealed together to form an integralballoon cover 892 in the manner previously described with regard toprevious integral balloon cover embodiments. Thus, the balloon rolls 890are disposed against the outer periphery of tunneling member 851 andheld in position by the integral balloon cover 892 as shown in FIG. 81.The laparoscope shaft 870 can also be seen disposed within the tunnelingmember 851 in FIG. 81.

[0259] As best seen in FIG. 75, the balloon cover 892 also covers partof the distal portion 872 of the channel guide 853 and the balloon rolls890 that are disposed therein, along with portions of the length of thetunneling member 851. The integral balloon cover 892 thus serves toassemble the balloon 855, tunneling member 851 and the channel guide 853into an integral package. The balloon cover 892 preferably encases allbut the distal tip of the rolled-up balloon, including those portions ofthe balloon rolls 890 that lie disposed within the channel guide 853 toeither side of the tunneling member 851. The distal tip of the balloon855 is preferably provided with a nipple or pocket 867 that matesagainst the blunt distal end of the tunneling member 851 to help protectagainst stretching or tearing of the balloon tip 867 during tunneling.The balloon cover 892 is also provided with slits or perforations 856that provide a weakened region in the balloon cover 892 to allow it tobreak open during balloon 855 inflation as previously described.

[0260] The tunneling member 851 is conveniently provided with aconcentric ring shaped handle 852 for grasping by the surgeon duringintroduction of the obturator/balloon assembly 850 through an incisionin the patient, and during tunneling to the desired location within thebody for subsequent balloon tissue dissection as hereinbefore described.An instrument seal 854 is preferably provided in the proximal end of thehandle 852 to make a substantially fluid tight seal between thetunneling member 851 and the laparoscope shaft 870 for reasons that willshortly become apparent.

[0261] Turning now to FIG. 76, the balloon 855 which as shown may have amanta ray shape of the type hereinbefore described, is provided with anarrowed neck 864 through which the tunneling member 851 is inserted.The neck 864 of the balloon 855 is preferably disposed between aninstrument body 876 (see FIG. 82) and the interior of the outermost ringend 887 of the channel guide 853. The balloon neck 864 is press fitbetween the instrument body 876 and the channel guide 853 to provide asubstantially fluid tight seal with the interior of the balloon 855.

[0262] The balloon 855 is also preferably provided with a ballooninflation lumen 865 that is in communication with the interior space ofthe balloon 855. A flexible hollow inflation tube 861 with an opendistal end 866 is inserted into the inflation lumen 865 and secured in afluid tight manner as previously described. A wye adapter 860 is securedto the inflation tube 861 and carries a male inflation fitting 859 withan integral check valve (not shown) and another tubular member 888 onwhich is mounted a pinch clamp 858 and a male evacuation fitting 857,all of the type previously described.

[0263] Balloon inflation is accomplished by closing the pinch clamp 858and after connecting the male inflation fitting 859 to a suitable fluidsource, such as a syringe (not shown) for example, injecting a suitableinflation medium, such as saline, for example, through the inflationtube 861 into the balloon inflation lumen 865 and into the interior ofthe balloon. When the balloon 855 is inflated, the integral ballooncover 892 is designed to separate along its weakened region (representedby perforations or slits 856 in FIGS. 75 and 76) to allow the balloon855 to expand as it unrolls and climbs out of the open distal portion ofthe channel guide 853 until it is fully expanded. The balloon 855 may bedeflated by connecting the evacuation fitting 857 to an evacuation port(not shown) such as an operating room suction system, for example. Thepinch clamp 858 is released to open the tube 888 to permit the salinesolution which had been introduced into the balloon 855 to be sucked outthrough the inflation lumen 865 to completely deflate the balloon 855.

[0264] With reference to FIGS. 79 and 80, in a preferred embodiment, thehollow tunneling member 851 is provided with an open distal end 893 sothat the distal end 895 of the laparoscope shaft 870 may be extendedthrough this open end 893 during balloon 855 inflation as illustrated inFIG. 80. By extending the distal end 895 of the laparoscope 862 outsidethe tunneling member 851 only a single transparent balloon layerobstructs laparoscopic visualization and increased resolution overprevious embodiments is possible. As illustrated in FIG. 79, thetunneling member 851 is provided with spaced apart slits 894 at itsdistal end. The slits 894 allow the distal open end 893 of the tunnelingmember 851 to expand slightly outwardly, thus permitting the distal end895 of the laparoscope 862 to be advanced outside the tunneling member851. Because the end of the tunneling member 851 is open to the interiorof the balloon 851 during inflation, an instrument seal 854 is providedat the proximal end of the tunneling member 851 to minimize leakage ofthe inflation medium from the proximal handle 852 portion duringinflation. Alternately, or in combination with instrument seal 854, thetunneling member 851 may have a necked down portion, as illustrated at887 in FIG. 82, to form a substantially fluid tight seal between thetunneling member 851 and the scope shaft 870 to protect against leakageout the proximal end of the tunneling member 851.

[0265] The cut-away cross section in FIG. 82 shows the proximal portionof the laparoscopic apparatus 849. As previously discussed, the balloonneck 864 is trapped in a fluid tight manner between the proximal ring887 of the channel guide 853 and the outer periphery of cylindricalinstrument body 886. Thus, the interior of the balloon 855 is sealed atthe proximal extremity of its elongated neck 864 by means of a press fitbetween the proximal ring 887, the neck 864, and the instrument body886. A cylindrical shaped tunneling member seal 884 of the typepreviously described is preferably inserted over the proximal end of theinstrument body 886 to form a substantially fluid tight seal between thetunneling member 851 and the channel guide 853. This seal 884 is used toprevent fluid from coming out the proximal end of the channel guide 853during balloon 855 inflation.

[0266] Operation and use of the laparoscopic apparatus 849 may now bebriefly described with reference to FIG. 83. After the laparoscopicapparatus 849 has been readied for use, a conventional laparoscope isinserted through the instrument seal 854 and into the hollow lumen ofthe tunneling member 851 until resistance is felt and the distalextremity 895 of the laparoscope shaft 870 can be assumed to restagainst the distal extremity of the tunneling member 851. The surgeonnext makes an incision 896 using conventional techniques at theappropriate location in the body of the patient. The incision location,of course, depends on the operation to be performed and is illustratedwith regard to hernia repair in FIG. 83 by way of example only. Aftermaking the incision 896, the apparatus 849 is oriented so that the openside of channel guide 853 faces away from the patient, and the distalextremity of the apparatus 849 is advanced through the incision. Thedistal extremity of the apparatus 849 is then used as an obturator totunnel through the appropriate tissue layers until the location ofinterest for subsequent balloon inflation and tissue dissection isfound. As the distal extremity of the apparatus 849 is being advancedthrough the tissue layers, the progress of the operation may be observedthrough the laparoscope 862 to aid the surgeon in locating importantanatomical landmarks. As hereinbefore described with regard to previousembodiments, during this tunneling stage, the distal end 895 of thelaparoscope 862 looks out through the open end 893 in the distalextremity of the tunneling member 851 and the distal portion of theballoon 867 which covers it. A straight tipped scope 862 will give thegreatest field of view out the distal opening 893 during the tunnelingprocess, but an angled scope 862 (as illustrated in FIG. 80) may be usedinstead.

[0267] After the desired location in the body has been found, perhapswith the aid of visual observation and manual palpation in addition tolaparoscopic observation, dissection can proceed to create an anatomicworking space. It should be noted that the tunneling member 851 shouldbe sized to an appropriate length for the particular operation beingperformed so that the channel guide 853 is advanced approximately halfof its length through the incision when tunneling is completed. Afterthe balloon suction pinch clamp 858 has been closed so as to seal offthe suction line, balloon inflation may proceed through the inflationfitting 859 as previously explained.

[0268] During inflation the tunneling member 851 and laparoscope 862 maybe pulled back slightly from the balloon by grasping the handle 852 andpulling back with one hand while holding the channel guide 853 inposition with the free hand. The distal portion of the laparoscope shaft895 may then be advanced through the open distal end 893 of thetunneling member 851, forcing open slits 894, to permit an unobstructedview from inside the balloon 855 of tissue dissection as the balloon 855unrolls and inflates as previously described. If an angular laparoscopeis employed, the scope may be rotated or otherwise manipulated at theproximal end so as to increase the field of view from within the balloon855.

[0269] After inflation is complete, the balloon may be deflated byopening the suction line pinch clamp 858 and applying suction throughmale fitting 857 by suitable means such as a syringe or an operatingroom suction line as previously described. Once deflated, the channelguide 853 may be held in position and the tunneling member 851 andlaparoscope 862 completely withdrawn from the channel guide 853 andballoon 855, either together or sequentially, leaving the channel guide853 and deflated balloon 855 within the incision 896 to provide a pathback to the previously dissected space.

[0270] Next, the tunneling member 851 is discarded and a trocar withcannula and skin seal assembly of the type hereinbefore described withreference to FIG. 40, may be slid over the distal end 895 of laparoscope862. While holding the channel guide 853 in place, the distal end 895 ofthe laparoscope 862 may be inserted back into the incision 896 site andadvanced into the previously dissected space using the channel guide 853to guide the scope shaft 870. While holding the laparoscope 862 togetherwith the trocar, cannula and skin seal assembly, the channel guide 853and the attached deflated balloon 855 may now be removed from thepatient through the incision 896. At this point, the trocar with cannulaand skin seal assembly can be advanced over the laparoscope shaft 870into the incision 896 and the skin seal secured in place as previouslydescribed. The operation may now proceed in the manner appropriate forthe particular procedure being performed.

[0271] Turning now to FIG. 84, yet another embodiment of the inventionis illustrated that adds the use of an endoscope guide member 880 to thelaparoscopic apparatus 849 illustrated in FIG. 75. The apparatus 898 isotherwise identical. Guide member 880 consists of a semi-rigid tube withthat may be formed of a suitable material such as plastic. Asillustrated in FIG. 86, guide member 880 is provided with a longitudinalslit 883 running the length of the tube portion to facilitate itsremoval from the apparatus 898 in accordance with the laparoscopicprocedures described below.

[0272] In a preferred embodiment, the endoscope guide 880 may bepositioned over the channel guide 853, balloon 855, and tunneling member851 assembly with its handle 881 oriented in the same direction as theopen portion of the U-shaped channel guide 853 which it partiallysurrounds. As shown in FIG. 86, the endoscope guide 880 is provided witha slit 883 that extends longitudinally along the complete underside ofthe guide 853. The slit 883 allows the endoscope guide 880 to separatefrom the balloon 855, channel guide 853, and tunneling member 851assembly as the balloon 855 is inflated after the tunneling member 851has been advanced to dispose the balloon 855 within the desiredlocation.

[0273] In a preferred embodiment, the endoscope guide 880 is alsoprovided with a rolled over handle 881 secured by appropriate means suchas staple 882 to the guide 880 as illustrated in FIG. 84. The handle 881at all times remains outside the incision where it can be accessed bythe surgeon. After balloon deflation, the distal portion of theendoscope guide 880 remains within the incision to preserve access tothe previously created space and provide a convenient means for guidingthe laparoscope 862 back into the space.

[0274] Use of the laparoscopic apparatus 898 is substantially similar tothat previously described with regard to the embodiment shown in FIG.75. As before, a conventional laparoscope 862 is inserted into the boreof the tunneling member 851 until its distal end 895 bottoms against thedistal end of the tunneling member 851 bore. After an incision is madein the desired location, the tunneling member 851 together with therolled up balloon 855 is inserted into the incision and advanced as anobturator to the desired location. Visualization during tunnelingdissection is as described before. The apparatus 898 is sized so thatapproximately half of the channel guide 853 and the proximal handle 881portion of the endoscope guide 880 remain outside the incision when thedesired location has been reached. The tunneling member 851 togetherwith the laparoscope 862 may be retracted from against the distal end867 of the balloon 855 during inflation so as to provide the necessaryclearance from the interior of the balloon to permit the distal end 895of the laparoscope 862 to be advanced outside the open end 898 of thetunneling member 851. Dissection may then be viewed through a singleballoon layer during inflation as before.

[0275] The addition of the endoscope guide 880 slightly alters theprocedure after deflation of the balloon 855. After balloon deflation,the tunneling member 851 and laparoscope 862 are completely removed fromthe channel guide 853 and balloon 855, thus leaving the endoscope guide880, the channel guide 853, and the deflated balloon 855 in place withinthe incision. The next step in this procedure is while holding theendoscope guide 880 in place, to remove the channel guide 853 and theattached balloon 855 through the incision. After discarding thetunneling member 851 and loading a trocar with cannula and skin sealassembly over the laparoscope 862, the distal end 895 of the scope 862is inserted back into the incision using the endoscope guide 880 as apath to the dissected space. After the space has been located, theendoscope guide 880 may be removed from the patient and the cannula/skinseal advanced and secured into the incision as before.

[0276] Another embodiment of the laparoscope apparatus incorporating theinvention is illustrated in FIG. 85. The laparoscopic apparatus 899 inthis embodiment differs from the previous FIG. 84 embodiment in that thelongitudinally extending open ended distal portion of the channel guide853 has been cut away, leaving only the proximal ring 887 portion andthe inner press fit instrument body 886 to seal the balloon neck 864 aspreviously described.

[0277] Use of this apparatus 899 is substantially similar to that of theprevious two embodiments. The apparatus 899 is introduced into anincision in the body; advanced to the desired location underlaparoscopic observation with the blunt tipped tunneling member 851serving as an obturator; the balloon 855 is then inflated underlaparoscopic observation, if desired, to achieve tissue dissection; andthe balloon 855 deflated, all as hereinbefore described. The tunnelingmember 851 and laparoscope 862 are then withdrawn from the incisionthrough the ring 887 leaving the deflated balloon 855 and endoscopeguide 880 in place. While holding the endoscope guide 880 in place, thering 887 and attached balloon neck 864, which at all times remainsoutside the incision, is grasped and pulled away from the patient towithdraw the deflated balloon 855 from the body through the incision.After the tunneling member 851 has been discarded, and the trocar withcannula and skin seal assembly loaded over the laparoscope 862, thedistal tip 895 of the laparoscope 862 is guided into the incision andthe previously created space using the endoscope guide 880 as a guide aspreviously described. The remainder of the procedure is identical tothat described with reference to FIG. 84.

[0278] Turning now to FIGS. 87-92, yet another laparoscopic apparatusthat provides for laparoscopic observation during tunneling andsubsequent balloon dissection or retraction is illustrated. In FIG. 87the laparoscopic apparatus 900 of this embodiment is illustrated in afully assembled state as it would be prior to insertion through anincision into the human body for the performance of laparoscopicprocedures as explained herein.

[0279] In a preferred embodiment, laparoscopic apparatus 900 includes atunneling member 913, handle 902, and balloon sleeve 903 together with aballoon (926 in FIGS. 90 and 91) and integral balloon cover 908. Thetunneling member 913 is inserted through the handle 902 and sleeve 903into the interior of the balloon 926. In FIGS. 87 and 89, the balloon926 is illustrated after it has been rolled or folded and secured to thedistal portion of the tunneling member 913 by means of an integralballoon cover 908 in the manner described with regard to prior integralballoon cover embodiments. The integral balloon cover 908 is providedwith slits or perforations 907 that permit the cover to separate andbreak away during balloon expansion as previously described. Asillustrated in FIGS. 88 and 89, a conventional laparoscope 909 may beinserted into the tunneling member 913 if laparoscopic observation isdesired. Thus, together with the rolled or folded balloon 926 and theintegral balloon cover 908, the tunneling member 913 serves as both ablunt tipped obturator and a laparoscope cover.

[0280] The tunneling member 913, which may be formed of a suitablemedical grade of plastic, such as polycarbonate, comprises an obturatorshaft 915, and an obturator handle 904. Handle 904 facilitates graspingand manipulation by the surgeon during performance of an operation. Theobturator shaft 915 is preferably transparent, and sufficiently rigid topermit tunneling through tissue layers within the human body. Thetunneling member 913 is provided with a hollow bore extending throughits entire longitudinal length from the proximal handle 904 portion tothe distal open ended tip 917 to accept the insertion of a conventionallaparoscope 909 (see FIG. 88).

[0281] In a preferred embodiment, the tunneling member 913 is removablyinserted through the bore (see cross-sectional view in FIG. 92) providedin handle 902 and balloon sleeve 903, and into the interior of therolled or folded balloon 926 (FIGS. 90 and 91). Like the tunnelingmember 913, the handle 902 and balloon sleeve 903 may be formed of asuitable medical grade plastic, such as polycarbonate. As bestillustrated in the cross-sectional view in FIG. 92, the proximal end ofballoon sleeve 903 mates against the distal portion of the handle 902and is secured in mating engagement therewith by the elongate balloonneck 927 which surrounds the sleeve and extends into the handle 902. Theballoon neck 927 is secured between the interior of the handle 902 andthe external periphery of the instrument body 933 by means of a pressfit between the handle 902 and the body 933. The press fit between thehandle 902 and the body 933 traps the balloon neck 927 therebetween andprovides a substantially fluid tight seal for the interior of theballoon 926.

[0282] Because the handle 902 is in communication with the interior ofthe balloon 926, seats 932 are inserted at the proximal and distal endsof the instrument body 933 to provide a substantially fluid tight sealbetween the interior bore of the handle 902 and the obturator shaft 915which passes therethrough. Thus positioned, the seals 932 prevent theballoon inflation medium, typically saline, from flowing out theproximal end of the handle 902. The seals 933 also add stability to theobturator shaft 915 relative to the instrument body 933 in the handle902 that it passes through.

[0283] The balloon 926 is provided with an inflation lumen 919 incommunication with the interior space of the balloon 926 for deliveringa suitable inflation medium, such as saline solution, to the interior ofthe balloon 926. A flexible hollow inflation tube 920 with an opendistal end is inserted into the balloon inflation lumen 919 and securedin a fluid tight manner as previously described. A wye adapter 921 issecured to the inflation tube 920 and carries a male inflation fitting922 with an integral check valve (not shown) and another tubular memberon which is mounted a pinch clamp 923 and a male evacuation fitting 924,all of the type previously described. The balloon 926 is inflated anddeflated in the same manner as described with regard to priorembodiments.

[0284] When assembled into a complete assemble (as illustrated in FIG.87), the obturator shaft 915 of the tunneling member 913 passes throughthe handle 902 and balloon guide 903 bores and extends into the interiorof a rolled balloon 926 (illustrated unrolled and flattened out withoutthe flaps that preferably comprise the integral balloon cover 908 inFIGS. 90 and 91) until the open distal end 917 of the obturator shaft915 presses against a nipple 930 provided in the balloon 926. As bestillustrated in FIGS. 90 and 91, showing the apparatus 900 with theballoon 926 unrolled and laid flat, a nipple or pocket 930 is providedin the balloon 926 to accept the open distal end 917 of the obturatorshaft 915. Use of the nipple 930 helps to prevent stretching or tearingof the balloon 926 during tunneling when the open distal end 917 of theobturator shaft 915 presses against the balloon material of the nipple930. The balloon 926 may have a manta ray shape as illustrated in FIGS.90 and 91, or it may be custom shaped for the particular procedure to beperformed.

[0285] In FIG. 89, a conventional laparoscope 909 is illustrated afterit has been fully inserted into the apparatus 900 to permit observationthrough its distal end (not shown) during tunneling and dissection. Thelaparoscope 909 includes a shaft 911 that is inserted through a bore inthe tunneling member 913 that extends from the proximal handle 904portion to the open ended distal tip 917 (FIG. 88). To prepare fortunneling dissection, the laparoscope 909, which may be a conventional10 mm laparoendoscope, for example, is inserted through the handleportion 904 of the tunneling member 913 and advanced through thetunneling member bore 914 until the distal extremity 931 of the scopeshaft 911 is captured by the lip 918 provided in the obturator shaft915. The lip 918 in the obturator shaft 915 thus prevents furtheradvancement of the laparoscope shaft 911, and retains the distal end 931of the shaft 911 within the confines of the obturator shaft 915. Thelaparoscope 909 is provided with a fiber optic light port 912 to provideillumination to the lens (not shown) located at the distal end of thescope shaft 931. Although an angled scope will provide the bestvisualization through the cut-away distal end 917 of the obturator shaft913, a straight scope may also be utilized.

[0286] As illustrated in FIG. 92, the distal end 917 of the obturatorshaft 915 is cut away at approximately a 45 degree angle to provided anopen end for unobstructed vision through the laparoscope 909 during bothtunneling and subsequent balloon dissection. An instrument seal 916which may comprise a pinched down region of the obturator shaft 915 asillustrated in FIG. 92, provides a substantially fluid tight sealbetween the laparoscope shaft 911 and the interior of the obturatorshaft 915 to prevent the balloon inflation medium, from escaping out theproximal end of the tunneling member 913 during balloon inflation. As analternative to the pinch seal 916, or in addition thereto, an instrumentseal of the type illustrated between the handle 902 and obturator shaft915 may be provided in the bore at the proximal end of the obturatorhandle 904 as previously described and illustrated with regard to theFIG. 75 embodiment.

[0287] During surgical use of the apparatus 900 as described herein,important physical structures and anatomical landmarks may be observedat the distal end 931 of the scope shaft 915 through eyepiece 910 (orviewing monitor, not shown) to guide the surgeon in locating the correctdissection plane. As can be appreciated from the construction of theapparatus 900 described above, by providing a cut away distal end 917 inthe obturator shaft 915, the surgeon's vision through the laparoscope909 during both tunneling and subsequent balloon 926 expansion isimpeded by only a single balloon 926 layer. After balloon inflation,when the balloon 926 has broken free of its cover 908 and separated fromthe obturator shaft 915, the tunneling member 913 together with thelaparoscope 909 may be advanced or retracted relative to the stationaryhandle 902 and balloon sleeve 903 assembly which remain outside theincision in the patient.

[0288] The surgical procedure for use of apparatus 900 may now bebriefly described. After the laparoscopic apparatus 900 has been readiedfor use, a conventional laparoscope 909 is inserted into the tunnelingmember 913, and advanced through the pinch seal 916 until the distalextremity 931 of the laparoscope shaft 911 is captured by lip 918. Thesurgeon next makes an incision using conventional techniques at theappropriate location, depending on the operation to be performed, in thebody of the patient. After making the incision, the apparatus 900 isadvanced through the incision with the distal extremity of the apparatus900 being used as an obturator to tunnel through the appropriate tissuelayers until the location of interest is located. As the distalextremity of the apparatus 900 is being advanced through the tissuelayers, the progress of the operation may be observed through thelaparoscope 909 to aid the surgeon in locating important anatomicallandmarks. As hereinbefore described with regard to previousembodiments, during this tunneling stage, the distal end 931 of thelaparoscope 909 looks out through the open (preferably cut at a 45degree angle) distal end 917 of the obturator shaft 915, obstructed byonly a single and preferably transparent balloon layer.

[0289] After the desired location in the body has been found, dissectionor retraction, as appropriate for the procedure, may be performed. Itshould be noted that the obturator shaft 915 is sized to an appropriatelength for the particular operation being performed. After the balloonsuction pinch clamp 923 has been closed so as to seal off the suctionline, balloon inflation may proceed through the inflation fitting 922 aspreviously explained.

[0290] During inflation the tunneling member 913 and laparoscope 909 maybe pulled back slightly from the balloon 926 by grasping the tunnelingmember handle 904 and pulling back with one hand while holding thehandle 902 in position with the free hand. The laparoscope 909 togetherwith the tunneling member 913 may then be manipulated, and rotated asdesired for unobstructed viewing from inside the balloon 926 of tissuedissection as the balloon 926 unrolls and inflates as previouslydescribed.

[0291] After inflation is complete, the balloon 926 may be deflated byopening the suction line pinch clamp 923 and applying suction throughmale fitting 924 by suitable means such as a syringe or an operatingroom suction line as previously described. Once deflated, thelaparoscope 909, tunneling member 913 and the handle 902, balloon guide903 and secured balloon 926 may be withdrawn, either together orsequentially through the incision.

[0292] If insufflation is required for the procedure or additionaltrocars are needed, a trocar with cannula and skin seal assembly of thetype hereinbefore described with reference to FIG. 40 may be slid overthe distal end 931 of laparoscope 909. The laparoscope 909 is theninserted back into the incision to access the previously created space,and the trocar with cannula sleeve and skin seal assembly may beadvanced over the laparoscope shaft 911 into the incision and the skinseal secured in place as previously described.

[0293] A greatly simplified embodiment that provides for laparoscopicobservation during both tunneling and balloon dissection once thedesired space has been reached is illustrated in FIG. 93. Thelaproscopic apparatus 940 includes a tunneling member 913, of the typepreviously described with reference to the FIG. 87 embodiment, and aballoon 926 with an elongate neck 943, and inflation lumen 919. Theelongate neck 943 may be folded inwardly and secured to the shaft 915 ofthe tunneling member 913 as illustrated at 942. The neck 943 ispreferably secured to the obturator shaft 915 by means of clamping,gluing, heat sealing or welding as previously described. Additionally,any one of a number of folding arrangements, including a multiplicity offolds, may be employed with regard to the balloon neck. By providingthis inward folding of the elongate neck 943, the tunneling member 913may be retracted from the balloon 926 during inflation and manipulatedto observe dissection as it is occurring without moving the position ofthe balloon 926 relative to the desired location.

[0294] The tunneling member 913 is as previously described with a handle904 at its proximal end and a hollow obturator shaft, adapted to accepta conventional laparoscope, extending distally from the handle 904. Theobturator shaft 915 is provided with an open distal end 917 that ispreferably cut-away at a 45 degree angle as before.

[0295] In FIG. 93, the balloon 926 is shown unrolled and flattened outto illustrate the open distal end 917 of the obturator shaft 915, andthe laparoscope shaft 911 that is inserted therein and captured at itsdistal end 931 by the lip 918 provided in the obturator shaft 915. Inpractice, the balloon 926 would be rolled or folded and secured relativeto the distal portion of the obturator shaft 915 by means of an integralballoon cover (not shown) in the manner previously described.Alternatively, the endoscope guide 880 (illustrated in FIG. 86) may beused to secure the rolled or folded balloon in place about the obturatorshaft 915. The endoscope guide 880 may be used in place of, or inaddition to an integral balloon cover. One advantage of using theendoscope guide 880 is that it may be left behind within the incision soas to preserve access to the dissected space after balloon deflation andremoval as described with reference to the FIGS. 84 and 85 embodimentsand further described herein.

[0296] Use of the apparatus 900 offers greatly simplified surgicalprocedures over previous embodiments. As with the FIG. 87 embodiment, aconventional laparoscope 909 is inserted into the tunneling member 913,and is advanced through pinch seal 916 (see FIG. 92 until the distalextremity 931 of the laparoscope shaft 911 is captured by lip 918. Afterthe incision is made in the patient, the apparatus 900 is advancedthrough the incision with the distal extremity of the apparatus 900 usedto tunnel through the appropriate tissue layers until the location ofinterest is located. If the optional endoscope guide 880 is used, thehandle 881 of the guide 880 will remain outside the incision tofacilitate later removal. As before, the progress of the operation maybe observed through the laparoscope 909 during tunneling dissection. Ashereinbefore described with regard to previous embodiments, during thistunneling stage the distal end 931 of the laparoscope 909 looks outthrough the open (preferably cut at a 45 degree angle) distal end 917 ofthe obturator shaft 915 obstructed by only a single and preferablytransparent balloon layer.

[0297] After the desired location in the body has been found, dissectionor retraction as appropriate for the procedure may be performed. Afterthe balloon suction pinch clamp 923 has been closed so as to seal offthe suction line, balloon inflation may proceed through the inflationfitting 922 as previously explained. If the optional endoscope guide 880is used, the guide 880 will separate from the rolled up balloon 926 wheninflation is started so as to permit the balloon 926 to freely expand.

[0298] During inflation the tunneling member 913 and laparoscope 909 maybe pulled back slightly from the balloon 926 by grasping the tunnelingmember handle 904 and retracting the tunneling member 913 together withthe laparoscope 909 inserted therein. The laparoscope 909 together withthe tunneling member 913 may then be manipulated, and rotated forviewing tissue dissection or retraction as desired, through a singleballoon layer from inside the balloon 926.

[0299] After inflation is complete, the balloon 926 may be deflated byopening the suction line pinch clamp 923 and applying suction throughmale fitting 924 by suitable means such as a syringe or an operatingroom suction line as previously described. Once deflated, thelaparoscope 909, and tunneling member 913 with the attached balloon maybe withdrawn, either together or sequentially through the incision. Ifthe endoscope guide 880 was used to retain access to the dissectedspace, the guide 880 is left in place within the incision.

[0300] If insufflation is required for the procedure or additionaltrocars are needed, a trocar with cannula and skin seal assembly of thetype hereinbefore described with reference to FIG. 40, may be slid overthe distal end 931 of laparoscope 909. The laparoscope 909 is theninserted back into the incision (using the endoscope guide 880 to findthe path back to the space if provided) to access the previously createdspace, and the trocar with cannula sleeve and skin seal assembly may beadvanced over the laparoscope shaft 911 into the incision and the skinseal secured in place as previously described.

[0301] Although the present invention has been principally described inconjunction with hernia repair, it should be appreciated that thevarious balloon constructions and the methods hereinbefore described canbe utilized in other surgical procedures. In connection with suchprocedures, if specialized or custom-type balloons are required for aspecific procedure, it can be seen that such balloon can be readilyconstructed in accordance with the present invention and utilized ashereinbefore described to perform those procedures. Examples of suchprocedures which would lend themselves to use of the balloon dissectorsherein disclosed and the methods utilizing the same can be utilized forextraperitoneal endoscopic pelvic lymph node dissection. Similarly, theballoon dissectors and procedures hereinbefore described areparticularly useful for curing stress urinary incontinence by the use ofbladder neck suspension procedures. In all of these procedures, it isdesirable to make them as minimally invasive as possible and, wherefeasible, to utilize extraperitoneal endoscopic procedures.

[0302] From the foregoing, it can be seen that the apparatus and methodor procedures of the present invention can be utilized in variouslaparoscopic surgical procedures. For example, the apparatus and methodcan be utilized with little or no shape modifications to the balloon forlymphadenectomies. Similarly, they can be used for bladder necksuspensions as hereinbefore described. Also, they can be used inretroperitoneal applications such as spinal and vascular procedures. Forvascular procedures, it should be useful for aortic and sympathectomyprocedures. They also can be utilized in urological applications forprocedures involving the kidney and adrenal glands. The horseshoe-shapedballoon described can be utilized for dissecting around obstructionssuch as ventral hernias and median raphes.

What is claimed is:
 1. An apparatus for creating an anatomic workingspace between tissue layers in a body comprising: a cannula having abore extending therethrough and a distal end; a hollow obturator havinga bore extending therethrough, said obturator insertable through saidcannula; a balloon having an elongate neck and an interior space incommunication with said neck, said obturator extending through saidcannula and into said balloon interior space, said elongate neck securedto said distal end of said cannula tube; retaining means for formingsaid balloon into a generally cylindrical roll and for releaseablysecuring said balloon to said obturator inserted therein; and means forinflating the balloon after it is disposed between the tissue layers tocause said balloon to progressively expand to create the anatomicworking space.
 2. Apparatus as in claim 1 wherein said obturator has adistal extremity with a rounded blunt end.
 3. Apparatus as in claim 2together with a laparoscope and wherein said obturator is provided witha bore sized to accommodate the laparoscope so that the laparoscope canbe positioned within the bore of the obturator and wherein the obturatorshaft is formed of a transparent material so that the laparoscope can beutilized for viewing through the obturator.
 4. Apparatus as in claim 1wherein said means for inflating comprises a housing and a valve membermovable between open and closed positions, said valve member being ableto accommodate said obturator to form a fluid-tight seal with theobturator when the obturator is introduced through said housing intosaid bore of said cannula.
 5. Apparatus as in claim 1 further comprisinga skin seal slidably mounted on the cannula.
 6. Apparatus as in claim 5wherein said skin seal includes means for clamping said skin seal sothat it remains in a predetermined position on the cannula.
 7. Apparatusas in claim 1 wherein said retaining means comprises an enclosing sleevesecured to said balloon having a weakened region extending along thelength thereof to permit said sleeve to separate upon expansion of saidballoon to release said balloon.
 8. Apparatus as in claim 1 furthercomprising an opaque baffle disposed in said bore of said obturator forpreventing unwanted reflections from entering a viewing element of alaparoscope disposed therein.
 9. Apparatus as in claim 1 furthercomprising means for introducing an insufflation gas into the anatomicspace.
 10. Apparatus as in claim 1 wherein said balloon is provided withside margins which are folded inwardly before the balloon is formed intosaid roll.
 11. Apparatus as in claim 1 wherein said balloon is formedwith integral longitudinally extending portions which form a part ofsaid retaining means.
 12. Apparatus as in claim 1 wherein said balloonis horseshoe-shaped and is provided with first and second spaced-apartlegs and wherein said legs are folded inwardly before said balloon isformed into said roll.
 13. Apparatus as in claim 12 wherein saidobturator underlies said balloon and wherein said first and secondspaced-apart legs are rolled into first and second rolls with said rollsbeing formed by rolling inwardly towards said obturator.
 14. Apparatusas in claim 1 wherein said balloon is folded inwardly into itself beforeit is formed into said roll.
 15. Apparatus as in claim 1 furthercomprising means for forming a fluid tight seal between said elongateballoon neck and said distal end of said cannula.
 16. Apparatus as inclaim 15 wherein said means for forming a fluid tight seal includes aninwardly extending annular tapered surface provided on said distal endof said cannula and a tubular member within said cannula movablelongitudinally of said cannula and carrying a tapered surface for matingwith said inwardly extending annular taper of the cannula to form afluid tight seal between said neck of said balloon and said cannula. 17.Apparatus as in claim 16 wherein said tubular member is provided with anopen distal extremity together with a laparoscope disposed in saidtubular member and extending through said open distal extremity. 18.Apparatus as in claim 16 wherein said tubular member is provided with aclosed end and wherein said tubular member is provided with a distalextremity of a smaller diameter and a proximal extremity of a largerdiameter than the distal extremity and wherein the taper carried by thetubular member is formed by a transition between the portion of smallerdiameter and the portion of larger diameter.
 19. Apparatus as in claim18 wherein said tubular member is provided with a bore together with alaparoscope disposed in said bore.